A Phase 2 interventional study of DEX IR tablets and DEX XL in Attention-Deficit/Hyperactivity Disorder (ADHD) and Depression - Major Depressive Disorder, sponsored by Prof. Dr. Frank Behrens. Recruiting at 5 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Prof. Dr. Frank Behrens · Phase 2, Interventional, and Treatment
Among 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany — 2 open to participants now, 2 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · Germany.
Among the 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany, this one is the 36th largest by planned enrollment of the 55 interventional ones, is one of 2 that started in 2025, is one of 3 in phase 2, and was the 61st registered.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's planned enrollment of 105 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →2 of the 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany are open now, in 1 country. Each count lists the studies.
Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →63 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 2 started in 2025.
Median enrollment 150 across the 55 interventional studies, 434 across the 8 observational. Of the 52 that completed or were terminated, 20 (38%) have results posted.
33 of 63 have an industry lead sponsor. The 10 most frequent:
Prof. Dr. Frank Behrens is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Prof. Dr. Frank Behrens has 1 study filed under Attention Deficit Disorder with Hyperactivity — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany, from their registry updates:
The indication of attention-deficit/hyperactivity disorder (ADHD) to be examined often occurs with other psychiatric disorders, and the majority of adults with ADHD have at least one psychiatric comorbidity in their lives. Depression is one of the most common comorbidities in patients with ADHD. The prevalence of comorbid depression in adults with ADHD is estimated to be as high as 50%.
There is evidence that stimulants such as dexamfetamine and methylphenidate lead to an improvement in sustained focused attention, working memory, and a variety of cognitive processes in the prefrontal cortex (PFC). In combination with the pharmacological effects of stimulants, such as the inhibition of monoamine oxidase, the increase in the concentration of noradrenaline in the PFC and dopamine in the striatum, dexamfetamine and methylphenidate could improve the treatment of depression in patients with major depressive disorder and comorbid ADHD.
This clinical trial will evaluate the safety and efficacy of DEX in two different formulations compared to placebo in adults with ADHD and moderate to severe depression. To ensure double blinding of the treatment, placebo will be administered in the form of tablets and capsules.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Current use of and use within the last 2 weeks before inclusion due to possible interactions with stimulants or SSRIs/SNRIs and possible resulting or expected side effects:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
tablets twice daily
Drug: DEX IR tablets
capsule once daily
Drug: DEX XL
tablet or capsule as comparator to verum
Drug: Placebo
tablet twice daily
capsule once daily
Placebo to either capsule or tablet
Incidence of adverse events (AE) in the active treatment groups compared to the placebo until V6
Incidence of adverse events (AE) in the active treatment groups (DEX XL and DEX IR) compared to the placebo until V6
Time frame: from enrollment to the end of study at week 17
Incidence of adverse events (AE) until V5
Dokumentation of AE
Time frame: Start with enrollment until end of treatment at Week 16
Proportion of patients with at least one AE until V5
Proportion of patients with at least one AE until V5
Time frame: through study treatment (up to 16 weeks)
Proportion of patients with at least one AE until end of study
Proportion of patients with at least one AE until end of study
Time frame: from baseline until end of study at week 17
Number of AE until V5
Number of AE
Time frame: through study treatment (up to 16 weeks)
Number of AE until V5 and until end of study
Number of AE
Time frame: from baseline until end of study at week 17
Number of AE/SAE during the study period
Number of AE/SAE
Time frame: through study treatment (up to 16 weeks)
number of patients with AE/SAE by type during study period
Number and type of AE/SAE
Time frame: through study treatment (up to 16 weeks)
proportion of patients with AE/SAE by type during study period
Proportion of patient with AE/SAE by type
Time frame: through study treatment (up to 16 weeks)
number of patients with AE/SAE by severity (mild, moderate, severe) during study period
number of patients with AE/SAE by severity (mild, moderate, severe)
Time frame: through study treatment (up to 16 weeks)
proportion of patients with AE/SAE by severity (mild, moderate, severe) during study period
proportion of patients with AE/SAE by severity (mild, moderate, severe)
Time frame: through study treatment (up to 16 weeks)
number of patients with AE/SAE by relatedness to treatment during study period
number of patients with AE/SAE by relatedness to treament
Time frame: through study treatment (up to 16 weeks)
proportion of patients with AE/SAE by relatedness to treatment during study period
proportion of patients with AE/SAE by relatedness to treatment
Time frame: from enrollment to the end of study at week 17
Score of clinical global impression (CGI) Efficacy index by investigator at Visit 5
Clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in patients with mental disorders. It is a brief 3-item observer-rated scale. 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects. Treatment is evaluated from "marked improvement" to "none/worsening". Side effects is evaluated from "none" to "outweigh therapeutic effect"
Time frame: 16 weeks after treatment start
MADRS suicidal ideation score for all available visits (screening to Visit 5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: from enrollment to the end of treatment (up to week 16)
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: from enrollment to end of titration at week 4 (V1)
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: from enrollment to week 7 (V2)
MADRS suicidal ideation score change to BL/V0 (on V1)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: from baseline to end of treatment titration phase at 4 weeks
MADRS suicidal ideation score change to BL/V0 (on V5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: from treatment start to end of treatment at 16 weeks
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: from enrollment to 10 weeks (V3)
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: from enrollment to 13 weeks (V4)
MADRS suicidal ideation score for all available visits (screening to visit 5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: from enrollment to 16 weeks (V5)
Rate of patients with score 1-3 in CGI-I at V5
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's \[average\] condition has...?" and rated as: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Time frame: from baseline to 16 weeks (V5)
Absolute scores categories of CGI-I at all available visits
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's \[average\] condition has...?" and rated as: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Time frame: from end of treatment titration phase at 4 weeks (V1) to week 7 (V2)
Absolute scores categories of CGI-I at all available visits (V1 to V2)
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's \[average\] condition has...?" and rated as: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Time frame: from end of titration phase (week 4) to 7 weeks (V2)
Absolute scores categories of CGI-I at all available visits (V1 to V3)
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's \[average\] condition has...?" and rated as: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Time frame: from end of titration phase (week 4) to 10 weeks (V3)
Absolute scores categories of CGI-I at all available visits (V1 to V4)
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's \[average\] condition has...?" and rated as: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Time frame: from end of titration phase (week 4) to 13 weeks (V4)
Absolute scores categories of CGI-I at all available visits (V1 to V5)
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's \[average\] condition has...?" and rated as: Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Time frame: from end of titration phase (week 4) to end of treatment at 16 weeks (V5)
Numbers and percentages of patients with (1) decreased, (2) maintained and (3) increased CGI-S at V5 compared to BL/V0
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: from baseline to end of treatment at 16 weeks (V5)
Shift table of CGI-S score categories at BL/V0
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: at baseline
Shift table of CGI-S score categories at V1
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: from baseline to end of treatment titration phase at 4 weeks (V1)
Shift table of CGI-S score categories at V5
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: from baseline to end of treatment at 16 weeks (V5)
Absolute score categories of CGI-S at V0
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: at baseline (V0)
Absolute score categories of CGI-S at V0 to V2
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: from baseline to 7 weeks (V2)
Absolute score categories of CGI-S at V0 to V1
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: from baseline to end of treatment titration phase at 4 weeks (V1)
Absolute score categories of CGI-S at V0 to V3
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: from baseline to 10 weeks (V3)
Absolute score categories of CGI-S at V0 to V4
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: from baseline to 13 weeks (V4)
Absolute score categories of CGI-S at V0 to V5
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are: Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Time frame: from baseline to end of treatment at 16 weeks (V5)
MADRS total score (range 0-60) for all available visits (SCR to V5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: Screening until end of treatment at week 16 (V5)
MADRS total score (range 0-60) MADRS total score (range 0-60) change to BL/V0 (at V5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: baseline until end of treatment at week 16 (V5)
MADRS total score categorization by Müller et al. at BL/ V0
MADRS total score categorization by Müller et al.: 0-6 absence of symptoms; 7-19 mild depression, 20-34 moderate depression, 35-60 indicate a severe depression.
Time frame: at baseline
ADHS-DC-Q total score (range 0-66) for all available visits (SCR to V5)
The ADHS-DC-Q consists of 18 items with a four-level response (not existing, slightly existing, moderately existing, strongly existing). The items ask about the current symptoms. The three scales are: lack of inattentiveness, hyperactivity and impulsiveness.
Time frame: Screening to end of treatment at week 16
ADHS-DC-Q total score (range 0-66) change to BL/V0 (V1)
The ADHS-DC-Q consists of 18 items with a four-level response (not existing, slightly existing, moderately existing, strongly existing). The items ask about the current symptoms. The three scales are: lack of inattentiveness, hyperactivity and impulsiveness.
Time frame: from baseline to end of titration at week 4 (V1)
QIDS-SR-16 total score (range 0-27) for all available visits (V0 to V5)
QIDS-SR-16 is a self-report measure of depression consisting of 16 items. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia), Sad mood, Decrease/increase in appetite/weight , Concentration , Self-criticism, Suicidal ideation, Interest, Energy/fatigue, Psychomotor agitation/retardation. Scoring is given from 0 to 3 whereas 0 indicates less impact, 3 highest impact in depression.
Time frame: baseline to end of treatment at 16 weeks
QIDS-SR-16 total score (range 0-27) change to BL/V0 (V5)
QIDS-SR-16 is a self-report measure of depression consisting of 16 items. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia), Sad mood, Decrease/increase in appetite/weight , Concentration , Self-criticism, Suicidal ideation, Interest, Energy/fatigue, Psychomotor agitation/retardation. Scoring is given from 0 to 3 whereas 0 indicates less impact, 3 highest impact in depression.
Time frame: from baseline to end of treatment at week 16 (V5)
Mean dose intake from V1 to V5 per treatment group
Mean dose intake from V1 to V5 per treatment group
Time frame: from end of titration (week 4, V1) until end of treatment at week 16
Mean dose intake compared to planned dose after titration phase (for study period V1 to V5) per treatment group
Mean dose intake compared to planned dose after titration phase per treatment group
Time frame: end of titration phase (visit 1) 4 weeks after baseline until end of treatment at week 16 (12 weeks after titration phase)
Proportion of patients with less than 80% of planned dose intake (for study period V1 to V5) per treatment group
Proportion of patients with less than 80% of planned dose intake per treatment group
Time frame: visit 1 (4 weeks after baseline) until end of treatment at week 16
Number of patients by dosage group at V1 and V2
Number of patients by dosage group (DEX IR: 10 mg, 15 mg, 20 mg, 30 mg; DEX XL: 10 mg, 15 mg, 20 mg, 30 mg; Placebo: 10 mg, 15 mg, 20 mg, 30 mg))
Time frame: at visit 1 (4 weeks after baseline) and at visit 2 (3 weeks after visit 1)
Proportion of patients by dosage group at V1 and V2
Proportion of patients by dosage group (DEX IR: 10 mg, 15 mg, 20 mg, 30 mg; DEX XL: 10 mg, 15 mg, 20 mg, 30 mg; Placebo: 10 mg, 15 mg, 20 mg, 30 mg))
Time frame: at visit 1 (4 weeks after baseline) and at visit 2 (3 weeks after visit 1)
Number of patients per treatment group that needed dose optimization of IMP in the optimal stable dose phase and type of optimization (e.g., downtitration)
Number of patients per treatment group that needed dose optimization of IMP in the optimal stable dose phase and type of optimization (e.g., downtitration)
Time frame: end of titration phase (visit 1) 4 weeks after baseline until end of treatment at week 16 (12 weeks after titration phase)
Proportion of patients per treatment group that needed dose optimization of IMP in the optimal stable dose phase and type of optimization (e.g., downtitration)
Proportion of patients per treatment group that needed dose optimization of IMP in the optimal stable dose phase and type of optimization (e.g., downtitration)
Time frame: end of titration phase (visit 1) 4 weeks after baseline until end of treatment at week 16 (12 weeks after titration phase)
Number of patients with early withdrawal from therapy due to adverse events
Number of patients with early withdrawal from therapy due to adverse events in total
Time frame: baseline until end of treatment at week 16 (12 weeks after end of titration phase)
Number of patients with early withdrawal from therapy due to adverse events per treatment group
Number of patients with early withdrawal from therapy due to adverse events per treatment group
Time frame: baseline until end of treatment at week 16 (12 weeks after end of titration phase)
percentage of patients with early withdrawal from therapy due to adverse events in total
Percentage of patients with early withdrawal from therapy due to adverse events - in total
Time frame: baseline until end of treatment at week 16 (12 weeks after end of titration phase)
Percentage of patients with early withdrawal from therapy due to adverse events per treatment group
Percentage of patients with early withdrawal from therapy due to adverse events per treatment group
Time frame: baseline until end of treatment at week 16 (12 weeks after end of titration phase)
MADRS total score categorization by Müller et al. at BL/ V0, V1 and V5
MADRS total score categorization by Müller et al.: 0-6 absence of symptoms; 7-19 mild depression, 20-34 moderate depression, 35-60 indicate a severe depression.
Time frame: at baseline, at end of titration phase (week 4) and at end of treatment (week 16, V5)
MADRS total score (range 0-60) MADRS total score (range 0-60) change to BL/V0 (at V1)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: baseline until end of titration phase at week 4 (V1)
ADHS-DC-Q total score (range 0-66) change to BL/V0 (V1)
The ADHS-DC-Q consists of 18 items with a four-level response (not existing, slightly existing, moderately existing, strongly existing). The items ask about the current symptoms. The three scales are: lack of inattentiveness, hyperactivity and impulsiveness.
Time frame: baseline until end of titration phase at week 4 (V1)
ADHS-DC-Q total score (range 0-66) change to BL/V0 (to V5)
The ADHS-DC-Q consists of 18 items with a four-level response (not existing, slightly existing, moderately existing, strongly existing). The items ask about the current symptoms. The three scales are: lack of inattentiveness, hyperactivity and impulsiveness.
Time frame: baseline until end of treatment at week 16 (V5)
QIDS-SR-16 total score (range 0-27) change to BL/V0 (V1)
QIDS-SR-16 is a self-report measure of depression consisting of 16 items. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia), Sad mood, Decrease/increase in appetite/weight , Concentration , Self-criticism, Suicidal ideation, Interest, Energy/fatigue, Psychomotor agitation/retardation. Scoring is given from 0 to 3 whereas 0 indicates less impact, 3 highest impact in depression.
Time frame: from baseline to end of titration (week 4, V1)
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Time frame: from enrollment to baseline (start of treatment, V0)
Started May 2025 (actual). Primary completion is estimated for Mar 2028, 34 months after the start.
Of 40 phase 2 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's planned 34 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Dec 2026 → Mar 2028 and completion Dec 2026 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Dextromethorphan
Attention Deficit Disorder with Hyperactivity →