A Phase 2 interventional study of OPC-64005 and Atomoxetine in Adult Attention Deficit Hyperactivity Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 26 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment
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Among 25 studies in Attention Deficit Disorder with Hyperactivity by Otsuka Holdings Co., Ltd. — 5 open to participants now, 5 under way, 5 of them phase 3. Attention Deficit Disorder with Hyperactivity · Otsuka Holdings Co., Ltd..
Among the 25 studies in Attention Deficit Disorder with Hyperactivity by Otsuka Holdings Co., Ltd., this one is the 11th largest by enrollment, is one of 2 that started in 2017, is one of 5 in phase 2, and was the 7th registered.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 295 are open to participants now.
Browse Attention Deficit Disorder with Hyperactivity studies →5 of the 25 studies in Attention Deficit Disorder with Hyperactivity by Otsuka Holdings Co., Ltd. are open now, in 2 countries. Recruiting first, the newest first:
Otsuka Pharmaceutical Development & Commercialization, Inc. · Sites in United States
Ages 18–65
Otsuka Pharmaceutical Co., Ltd. · Sites in Japan
Ages 6–17
Otsuka Pharmaceutical Co., Ltd. · Sites in Japan
Ages 6–17
Otsuka Pharmaceutical Co., Ltd. · Sites in Japan
Ages 18–55
Otsuka Pharmaceutical Co., Ltd. · Sites in Japan
Ages 18–55
By country, each count listing its 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 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
25 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 7 · Phase 3 12
First in 2010; this study’s year is marked. 2 started in 2017.
This study's enrollment of 239 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Median enrollment 180 across the 25 interventional studies. Of the 20 that completed or were terminated, 8 (40%) have results posted.
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This study is registered under Otsuka Pharmaceutical Development & Commercialization, Inc., one of the names counted as Otsuka Holdings Co., Ltd.. Under that name alone:
Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 297 studies on the registry; 19 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.
3 of the studies in Attention Deficit Disorder with Hyperactivity by Otsuka Holdings Co., Ltd. that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07759154Phase 3Otsuka Pharmaceutical Development & Commercialization, Inc.A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation | 2027-05-27 |
| NCT07087327Phase 3Otsuka Pharmaceutical Co., Ltd.A Long-term Trial of EB-1020 in Pediatric Patients With ADHD | 2027-08 |
| NCT07086313Phase 3Otsuka Pharmaceutical Co., Ltd.A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD | 2027-08 |
Add all 3 to your calendar (.ics) → With an account.
Among the 25 studies in Attention Deficit Disorder with Hyperactivity by Otsuka Holdings Co., Ltd., from their registry updates:
Nothing recorded among them since 2026-09-25.
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A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.
A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design trial.
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:
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.
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the titration period, participants received OPC-64005 two 10 milligram (mg) tablets, and one OPC-64005-matching placebo tablet along with two atomoxetine-matching placebo capsules, orally, once daily (QD), from Day 1 up to Day 4. During the treatment period, participants received OPC-64005 three 10 mg tablets, and two atomoxetine-matching placebo capsules, orally, QD, from Day 5 up to Day 56. The dose was reduced to 20 mg if the 30 mg dose in the treatment period was not tolerable.
Drug: OPC-64005 · Drug: Placebo
During the titration period, participants received atomoxetine one 40 mg capsule and one atomoxetine-matching placebo capsule along with three OPC-64005-matching placebo tablets, orally, QD, from Day 1 up to Day 4. During the treatment period, participants received two atomoxetine 40 mg capsules and three OPC-64005-matching placebo tablets, orally, QD, from Day 5 up to Day 56. The dose was reduced to 40 mg if the 80 mg dose in the treatment period was not tolerable.
Drug: Atomoxetine · Drug: Placebo
Participants received three OPC-64005-matching placebo tablets and two atomoxetine-matching placebo capsules, orally, QD, from Day 1 up to Day 56.
Drug: Placebo
OPC-64005 film coated tablets
Atomoxetine gelatin capsules
OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Change From Baseline in Conners' Adult ADHD Rating Scales-Observer: Screening Version (CAARS-O:SV) 18-item ADHD Symptoms Total Score at Day 56
The investigator-administered CAARS-O:SV consists of 18 items based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). It includes a 9-item inattentive symptom subscale and a 9-item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. The total score is the sum of individual scores and can range from 0 to 54. Higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement.
Time frame: Baseline, Day 56
Change From Baseline in CAARS-O:SV 18-item Score on Days 7, 14, 21, 28, 42, and 56
The investigator-administered CAARS-O:SV consists of 18 items based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. It includes a 9-item inattentive symptom subscale and a 9- item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. The total score is the sum of individual scores and can range from 0 to 54. Higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement.
Time frame: Baseline, Days 7, 14, 21, 28, 42, and 56
Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) With Adult Prompts Score on Day 28 and Day 56
The AISRS consists of 18-items derived from DSM-IV criteria for ADHD symptoms. The AISRS total score is the sum of the 9-item inattentive symptoms subscale and 9-item hyperactive and impulsive symptoms subscale. Each item is scored as follows: 0=none, 1=mild, 2=moderate, and 3=severe. The score for each subscale can range from 0 to 27. The total score can range from 0 to 54. A negative change from Baseline indicates improvement.
Time frame: Baseline, Days 28 and 56
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score on Days 7, 14, 21, 28, 42, and 56
The CGI-S evaluates the severity of individual symptoms and treatment response in participants with mental disorders. It is a 7-point scale that that requires the clinician to rate the severity of the participant's illness at the time of assessment as 0=not assessed, 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants. The score 0=not assessed was set to missing. A negative change from Baseline indicates improvement.
Time frame: Baseline, Days 7, 14, 21, 28, 42, and 56
Clinical Global Impression-Improvement (CGI-I) Score on Days 7, 14, 21, 28, 42, and 56
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention and rated as: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. The score of 0 =not assessed was set to missing. Lower scores indicate improvement.
Time frame: Baseline, Days 7, 14, 21, 28, 42, and 56
Change From Baseline in Conners' Adult ADHD Rating Scales-Self-Report: Screening Version (CAARS-S:SV) 18-item Total Score on Days 7, 14, 21, 28, 42, and 56
The CAARS-S:SV comprises of 30 items to measure symptoms for ADHD in adults but was limited to the 18 DSM-5 criteria relevant items for this trial. The 18-item ADHD Symptoms total score is the sum of the 9-item inattentive symptoms subscale and the 9-item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. Total score can range from 0 to 54. A negative change from Baseline indicates improvement.
Time frame: Baseline, Days 7, 14, 21, 28, 42, and 56
Change From Baseline in Adult ADHD Quality of Life Scale (AAQoL) Total Score on Day 28 and Day 56
The AAQoL is a validated, 29-item instrument for measuring the impact of ADHD symptoms on quality of life. The scale assesses 4 distinct functional domains based on the following subscales: life productivity (11 items), psychological health (6 items), life outlook (7 items), and relationships (5 items). Scores for individual items range from 1=never/not at all to 5=extremely/very often. Total and subscale scores were computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale and total scores. Higher scores indicate a greater impact.
Time frame: Baseline, Days 28, and 56
OPC-64005 Potential for Abuse Liability and Dependence as Assessed by the Drug Effects Questionnaire (DEQ) Score
The DEQ was used to assess the potential for abuse of OPC-64005. It is a 5-item questionnaire completed by the participant that includes the following questions: 1. Do you feel a drug effect right now? 2. Are you high right now? 3. Do you dislike any of the effects you are feeling right now? 4. Do you like any of the effects you are feeling right now? 5. would you like more of the drug you took, right now? Each item is rated on a 100-point scale of 1 (not at all) to 100 (extremely). 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Time frame: Baseline, Days 7, 14, 21, 28, 42, and 56
Participants took part in the study at 26 sites in the United States from 09 November 2017 to 31 October 2018.
| Milestone | OPC-64005 | Atomoxetine | Placebo |
|---|---|---|---|
| Started | 77 | 80 | 82 |
| Completed | 38 | 44 | 57 |
| Not completed | 39 | 36 | 25 |
| Withdrew: Adverse event | 18 | 11 | 7 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 5 | 3 | 6 |
| Withdrew: Non-compliance with investigational medicinal product (imp) | 2 | 2 | 0 |
| Withdrew: Physician decision | 0 | 1 | 2 |
| Withdrew: Protocol deviation | 8 | 9 | 4 |
| Withdrew: Withdrawal by subject | 6 | 8 | 6 |
| Withdrew: Day 56 visit was 15 days out of the visit window | 0 | 1 | 0 |
The investigator-administered CAARS-O:SV consists of 18 items based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). It includes a 9-item inattentive symptom subscale and a 9-item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. The total score is the sum of individual scores and can range from 0 to 54. Higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement.
| score on a scale | OPC-64005 | Atomoxetine | Placebo |
|---|---|---|---|
| Baseline | 40.71 ± 6.99 | 41.59 ± 6.66 | 40.51 ± 7.10 |
| Change at Day 56 | -19.4 ± 17.79 | -20.2 ± 13.24 | -10.3 ± 13.52 |
The investigator-administered CAARS-O:SV consists of 18 items based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. It includes a 9-item inattentive symptom subscale and a 9- item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. The total score is the sum of individual scores and can range from 0 to 54. Higher scores indicate worsening of symptoms. A negative change from Baseline indicates improvement.
Results for this outcome have not been posted.
The AISRS consists of 18-items derived from DSM-IV criteria for ADHD symptoms. The AISRS total score is the sum of the 9-item inattentive symptoms subscale and 9-item hyperactive and impulsive symptoms subscale. Each item is scored as follows: 0=none, 1=mild, 2=moderate, and 3=severe. The score for each subscale can range from 0 to 27. The total score can range from 0 to 54. A negative change from Baseline indicates improvement.
Results for this outcome have not been posted.
The CGI-S evaluates the severity of individual symptoms and treatment response in participants with mental disorders. It is a 7-point scale that that requires the clinician to rate the severity of the participant's illness at the time of assessment as 0=not assessed, 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants. The score 0=not assessed was set to missing. A negative change from Baseline indicates improvement.
Results for this outcome have not been posted.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a Baseline state at the beginning of the intervention and rated as: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. The score of 0 =not assessed was set to missing. Lower scores indicate improvement.
Results for this outcome have not been posted.
The CAARS-S:SV comprises of 30 items to measure symptoms for ADHD in adults but was limited to the 18 DSM-5 criteria relevant items for this trial. The 18-item ADHD Symptoms total score is the sum of the 9-item inattentive symptoms subscale and the 9-item hyperactive and impulsive symptoms subscale. Each item is rated on a scale of 0 to 3 where 0=not at all, never; 1=just a little, once a while; 2=pretty much, often; and 3=very much, very frequently. The score for each subscale can range from 0 to 27. Total score can range from 0 to 54. A negative change from Baseline indicates improvement.
Results for this outcome have not been posted.
The AAQoL is a validated, 29-item instrument for measuring the impact of ADHD symptoms on quality of life. The scale assesses 4 distinct functional domains based on the following subscales: life productivity (11 items), psychological health (6 items), life outlook (7 items), and relationships (5 items). Scores for individual items range from 1=never/not at all to 5=extremely/very often. Total and subscale scores were computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale and total scores. Higher scores indicate a greater impact.
Results for this outcome have not been posted.
The DEQ was used to assess the potential for abuse of OPC-64005. It is a 5-item questionnaire completed by the participant that includes the following questions: 1. Do you feel a drug effect right now? 2. Are you high right now? 3. Do you dislike any of the effects you are feeling right now? 4. Do you like any of the effects you are feeling right now? 5. would you like more of the drug you took, right now? Each item is rated on a 100-point scale of 1 (not at all) to 100 (extremely). 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Results for this outcome have not been posted.
Collected over From first dose up to 30 days post last dose of study drug (Up to approximately 12 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OPC-64005 | 0/77 (0%) | 1/77 (1.3%) | 61/77 (79.2%) |
| Atomoxetine | 0/79 (0%) | 0/79 (0%) | 59/79 (74.7%) |
| Placebo | 0/82 (0%) | 0/82 (0%) | 38/82 (46.3%) |
| Event | OPC-64005 | Atomoxetine | Placebo |
|---|---|---|---|
| Suicide attemptPsychiatric disorders | 1/77 | 0/79 | 0/82 |
| Event | OPC-64005 | Atomoxetine | Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 14/77 | 20/79 | 2/82 |
| Dry mouthGastrointestinal disorders | 15/77 | 9/79 | 2/82 |
| Decreased appetiteMetabolism and nutrition disorders | 13/77 | 12/79 | 2/82 |
| FatigueGeneral disorders | 7/77 | 12/79 | 4/82 |
| DizzinessNervous system disorders | 6/77 | 6/79 | 2/82 |
| HeadacheNervous system disorders | 6/77 | 6/79 | 3/82 |
| InsomniaPsychiatric disorders | 6/77 | 4/79 | 2/82 |
| Erectile dysfunctionReproductive system and breast disorders | 6/77 | 3/79 | 0/82 |
| ConstipationGastrointestinal disorders | 5/77 | 3/79 | 0/82 |
| SomnolenceNervous system disorders | 2/77 | 5/79 | 4/82 |
Randomized Analysis Set included all participants who were randomized in the trial.
| Age, Continuous(years) | OPC-64005 | Atomoxetine | Placebo | Total |
|---|---|---|---|---|
| Mean | 35.8 ± 8.6 | 35.1 ± 8.8 | 34.6 ± 9.3 | 35.1 ± 8.9 |
| Sex: Female, Male(Participants) | OPC-64005 | Atomoxetine | Placebo | Total |
|---|---|---|---|---|
| Female | 39 | 46 | 42 | 127 |
| Male | 38 | 34 | 40 | 112 |
| Race/Ethnicity, Customized(Participants) | OPC-64005 | Atomoxetine | Placebo | Total |
|---|---|---|---|---|
| Race — White | 58 | 60 | 64 | 182 |
| Race — Black or African American | 7 | 15 | 12 | 34 |
| Race — American Indian or Alaska Native | 3 | 2 | 2 | 7 |
| Race — Asian | 2 | 1 | 2 | 5 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 | 2 |
| Race — Other | 7 | 1 | 1 | 9 |
| Race/Ethnicity, Customized(Participants) | OPC-64005 | Atomoxetine | Placebo | Total |
|---|---|---|---|---|
| Ethnicity — Hispanic or Latino | 21 | 18 | 17 | 56 |
| Ethnicity — Not Hispanic or Latino | 55 | 62 | 65 | 182 |
| Ethnicity — Unknown | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Data sharing details ↗ · clinical-trials.otsuka.com
Ran from Nov 2017 to primary completion in Oct 2018, 11 months.
Results were first posted in Oct 2021, 2 years 11 months after primary completion. A results delay was requested in Oct 2019.
Of 24 industry-sponsored phase 2 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's 11 months is close to that.
Counting every sponsor, half of 40 studies reached it within 15 months; a quarter within 5 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity →
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