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CompletedNCT03785223Updated Oct 26, 2023

A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity

A Phase 4 interventional study of Methylphenidate Hydrochloride Controlled-Release Capsules and Placebo Capsule in Attention Deficit Hyperactivity Disorder, Generalized Anxiety Disorder and Social Anxiety Disorder, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by McMaster University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Other psychiatric disorders, including anxiety, often co-occur with adult ADHD; with 85% of ADHD patients having at least one other psychiatric condition. The presence of a co-occurring anxiety disorder has been associated with additive clinical effects, leading to more global impairment, poorer outcome, greater resistance to treatment and increased costs of illness. Stimulants are effective first-line treatments for adult ADHD patients, however the literature has mostly examined these treatments in pure ADHD populations (i.e. without other psychiatric disorders). Thus, there is little information to guide physicians in making treatment decisions for patients with ADHD and a co-occurring condition.

This trial aims to evaluate the efficacy and safety of methylphenidate hydrochloride controlled release capsules (Foquest) in treating adults aged 18-65 years with DSM-5 ADHD with and without a co-occurring anxiety disorder.The study uses a 14-week, randomized, placebo-controlled, cross-over design.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
  • Generalized Anxiety Disorder
  • Social Anxiety Disorder
  • Panic Disorder
  • Agoraphobia

Keywords

  • ADHD
  • Anxiety Disorders
  • Stimulants
  • Methylphenidate
03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's enrollment of 60 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Browse McMaster University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Outpatient men and women between 18 and 65 years who meet criteria for Current ADHDalone or with one of the following DSM-5 diagnoses: GAD, SAD,PD or Agoraphobia. Major Depressive Disorder or Persistent Depressive Disorder will be allowed, providing the severity is considered moderate or less, as defined by a score on the Montgomery Depressive Rating Scale-MADRS score of ≤ 25.
  2. ADHD rating scale for DSM-5 (ADHD-5-RS) score ≥ 24.
  3. Concomitant treatment with selective serotonin reuptake inhibitors (SSRI's), serotonin noradrenaline reuptake inhibitors (SNRI's), benzodiazepines, beta-blockers, atypical anti-psychotics, anti-epileptics is allowed, provided the dose has been stable for 8 weeks prior to study entry. Dose changes of allowed concomitant medication should be avoided during the treatment phases of the study.
  4. The ability to comprehend and satisfactorily comply with protocol requirements.
  5. Written given prior to entering the baseline period of the study.
  6. All women of child bearing potential must have a negative screening visit serum or urine pregnancy test and be using adequate for the duration of the study. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to provide additional protection against accidental pregnancy.

Exclusion criteria

Exclusion Criteria:

  1. Participants who currently fulfill criteria for a lifetime history of bipolar disorder, schizophrenia or other psychotic disorders, delirium, dementia and amnesic and other cognitive disorders, severe head injury, autism spectrum disorders, or are in a current agitated state.
  2. Participants with a history of seizure disorders, or an unstable medical condition will also be excluded.
  3. Participants with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviours within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
  4. Current treatment with a stimulant.
  5. A history of > 2 failed trials of adequately dosed psychostimulants for Adult ADHD.
  6. Patients receiving current psychotherapy, including cognitive behavioural therapy for either ADHD or an anxiety disorder, within 4 weeks prior to the baseline period.
  7. Patients who are known to be allergic to methylphenidate or components of methylphenidate hydrochloride, have known or idiosyncrasy to methylphenidate hydrochloride.
  8. Patients who have thyroid pathology, treatment of which has not been stabilized for at least 3 months.
  9. MAO inhibitors within 3 weeks of the start of the baseline.
  10. Individuals meeting criteria for current cannabis use disorder or substance use disorder will be excluded.
  11. Current use of bupropion or tri-cyclic antidepressants, with the exception of clomipramine.
  12. Current use of clonidine, modafinil or atomoxetine.
  13. Previous intolerance or failure to respond to an adequate trial of methylphenidate hydrochloride controlled release capsules (defined as a minimum of 55mg per day for at least 4 weeks).
  14. Patients who have a history or evidence of a medical condition that would expose them to an increase or significant adverse event or interfere with assessments of safety and efficacy during the course of the trial including: advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, or other pre-existing cardiac abnormalities or other serious cardiac problems.
  15. Patients with a history of Glaucoma.
  16. Sleep medications during the study period are excluded with the exception of zopiclone and zolpidem and melatonin.
  17. Patients using any herbal psychoactive treatments, eg; St.John's Wort, Valerian, Kava Kava, or Chamomile Extract within 14 days prior to randomization.
  18. Patients who have received electroconvulsive therapy within the previous 6 months.
  19. Patients with any condition or on any therapy that in the investigator's opinion or as indicated in the methylphenidate hydrochlorideproduct label, that may pose a risk to the subject or interfere with the study objective.
  20. Patients having abnormal laboratory or findings not resolved by the baseline examination.
  21. Patients with a proximal family history of sudden, unexplained cardiac death.
Terms in these criteria, in plain language(6)

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.

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.

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.

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.

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.

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Methylphenidate Hydrochloride Controlled-Release Capsules

    Flexibly dosed at 25-100 mg per day

    Drug: Methylphenidate Hydrochloride Controlled-Release Capsules

  • Placebo comparator
    Placebo Capsules

    1-4 capsules daily

    Drug: Placebo Capsule

Interventions

  • DrugMethylphenidate Hydrochloride Controlled-Release Capsules

    25 mg methylphenidate hydrochloride- titrated as tolerated up to a maximum 4 capsules daily (25 mg- 100 mg total dose) At Week 0 or Week 7, dosing will start at 1 capsule/day for one week, and be titrated to 2 capsules/day for Week 2. 50 mg of methylphenidate hydrochloride per day (i.e. 2 capsules/day) is the minimum dose that must be achieved. The dose may be titrated to 75 mg/day for Week 3 and to 100 mg/day for Week 4 if participants are tolerating their current dose, are experiencing no adverse events, and have not fully responded. By Week 4 or Week 11, no further dose changes will occur.

    Also known as: Foquest

  • DrugPlacebo Capsule

    At Week 0 or Week 7, dosing will start at 1 capsule/day for one week, and be titrated to 2 capsules/day for Week 2. The dose may be titrated to 75 mg/day for Week 3 and to 100 mg/day for Week 4 if participants are tolerating their current dose, are experiencing no adverse events, and have not fully responded. By Week 4 or Week 11 no further dose changes will occur.

06

What researchers measure

Primary outcomes

  1. Attention Deficit and Hyperactivity Rating Scale - 5

    The ADHD-RS-5 is a scale for children and adolescents that assesses the frequency and severity of ADHD symptoms and impairments based on criteria from the Diagnostic Statistics Manual 5. The measure will be adapted for use with adults as a clinician rated scale in this study. It consists of 18 items, rated on a 4-point scale from 0 (never or rarely) to 3 (very often). The items can be summed to obtain a total score (range: 0-54), an Inattention subscore (range:0-27), and a Hyperactivity-Impulsivity subscore (range: 0-27), with higher scores indicating greater frequency and severity of symptoms.

    Time frame: Change from baseline to Week 12

Secondary outcomes

  1. Hamilton Anxiety Rating Scale (HAM-A)

    The 14-item HAM-A was developed to assess general anxiety symptoms in a clinical population and has proven sensitive to change with treatment. It is a clinician-rated measure and will be administered by a trained, blinded rater, using the Structured Interview Guide for the HAM-A. It has 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) are summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.

    Time frame: Change from baseline to Week 12

  2. Clinical Global Impression - Severity (CGI-S)

    The CGI-S is a clinician-rated instrument used to assess global severity of symptoms. The CGI-S ranges from 1 (normal, not ill) to 7 (among the most severely ill).

    Time frame: Change from baseline to Week 12

  3. Clinical Global Impression - Improvement (CGI-I)

    The CGI-I is a clinician-rated instrument used to assess overall improvement of illness. The CGI-I ranges from 1 (very much improved) to 7 (very much worse).

    Time frame: Change from baseline to Week 12

  4. Montgomery-Åsberg Depression Rating Scale (MADRS)

    The MADRS is a clinician rated scale evaluating depressive symptoms. It consists of 10 items assessed on a 7-point scale (range: 0-6). The total score ranges from 0 to 60, with higher scores indicating greater severity of depressive symptoms.

    Time frame: Change from baseline to Week 12

  5. Barkley Adult ADHD Rating Scale (BAARS-IV)

    Self-report scale evaluating ADHD symptoms. Symptom count scores range from 1 to 27, with higher scores indicating more ADHD symptoms. Total scores range from 27 to 108, with higher scores indicating greater severity of symptoms.

    Time frame: Change from baseline to Week 12

  6. Weiss Functional Impairment Rating Scale-Self Report (WFIRS-S)

    The WFRIS is a self-reported measure of functional impairment associated with ADHD in various clinically-relevant domains of functioning. It examines both symptoms and behviours or emotional problems that may have impacted each functioning in each domain. It consists of 70 items, rated on a 4-point scale from 0 (never or not at all) to 3 (very often or very much). Total scores range from 0 to 210, with higher scores indicative of greater ADHD-related functional impairment. Subscores may be calculated for specific domains by summing the items within that section: family (range: 0-24), work (range: 0-33), school (range: 0-33), life skills (range: 0-36), self-concept (range: 0-15), social (range: 0-27), and risk (range: 0-42).

    Time frame: Change from baseline to Week 12

  7. Barkley Deficits in Executive Functioning Scale (BDEFS)

    The BDEFS is an adult self-report measure of executive functioning skills in daily life activities. It contains 20 items assessed on a 4-point scale ranging from 1 (never or rarely) to 4 (very often). The total score ranges from 20-80, with higher scores indicating greater deficit in executive functioning skills relevant to daily activities.

    Time frame: Change from baseline to Week 12

  8. Overall Anxiety Severity and Impairment Scale (OASIS)

    The OASIS is a self-report measure assessing the severity and impairment associated with anxiety disorders. It contains 5 items rated on a 5-point scale (range: 0-4). The total score ranges from 0-20, with greater scores indicating greater severity of anxiety and related impairment.

    Time frame: Change from baseline to Week 12

  9. Obsessive Compulsive Inventory - Revised (OCI-R)

    The OCI-R is a self-report scale for assessing symptoms of Obsessive-Compulsive Disorder (OCD). It consists of 18 questions with a 5-point scale (range: 0 to 4). The possible range of scores is 0 to 72, with higher scores indicating a greater likelihood of the presence of OCD.

    Time frame: Change from baseline to Week 12

  10. Quick Inventory of Depressive Symptoms (QID-SR-16)

    The QIDS is a self-report measure of depression. It contains 16 items with a 4-point scale (range: 0 to 3) which assess the severity of the nine diagnostic symptom criteria used in the DSM: Sleep disturbance, sad mood, decrease/increase in appetite/weight, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, and psychomotor agitation/retardation. The total possible score is ranged from 0 to 27, with higher scores representing greater severity of depression.

    Time frame: Change from baseline to Week 12

  11. Sheehan Disability Scale (SDS)

    The SDS is a 3 question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Each sub-scale score ranges from 0 to 10 and a total disability score, calculated as the sum of scores for each question ranges from 0 to 30. Higher scores reflect greater impairment.

    Time frame: Change from baseline to Week 12

  12. Social Phobia Inventory (SPIN)

    The SPIN is a self-report questionnaire measuring the severity of social anxiety symptoms. It consists of 17 items assessed on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The total possible score ranges from 0-68, with higher scores representing greater severity of social anxiety symptoms.

    Time frame: Change from baseline to Week 12

  13. Generalized Anxiety Disorder-7

    The GAD-7 is a self-reported questionnaire that measures the severity of various signs of GAD. It contains seven items with a 4-point scale (range: 0 to 3). The total possible score is ranged from 0 to 21, with higher scores representing greater severity of GAD.

    Time frame: Change from baseline to Week 12

  14. Panic and Agoraphobia Scale (PAS)

    The PAS is a measure of the severity of illness in patients with panic disorder (with or without agoraphobia). It has 13 items with a 5-point scale (range: 0-4). The total possible score is ranged from 0 to 52, with higher scores representing increased severity of illness. It contains 5 sub-scales: panic attacks, agoraphobic avoidance, anticipatory anxiety, disability, and functional avoidance (health concerns).

    Time frame: Change from baseline to Week 12

  15. PTSD Checklist for DSM-5 (PCL-5)

    The PCL-5 is a 20 item self-report measure that assesses symptoms of PTSD. Each item is rated on a 5-point scale from 0 (not at all) to 4 (extremely). The possible range of scores is 0 to 80, with higher scores indicating greater severity of PTSD.

    Time frame: Change from baseline to Week 12

  16. Drug Abuse Screening Test (DAST)

    The DAST is a self-report measure used to identify individuals that are abusing drugs (not including alcohol). It contains 20 items requiring a "yes" or "no" response, of which "yes" is scored as 1 and "no" is scored as 0 for 18 items, and "yes" is scored as 0 and "no" is scored as 1 for 2 items. The total score ranges from 0-20, with higher scores indicated a greater degree of drug use and misuse issues.

    Time frame: Change from baseline to Week 12

  17. Alcohol Use Disorders Identification Test (AUDIT)

    The AUDIT is a self-report screening test that assesses alcohol consumption, drinking behaviours, and alcohol-related problems. It consists of 20 items, 8 of which are rated on a 4-point scale from 0-4, and 2 of which are rated on a 3-point scale from 0, 2 and 4. The items are summed to obtain a total score ranging from 0-40, with higher scores indicating a greater degree of risky drinking. Consumption and dependance subscores (range: 0-12) may also be calculated by summing specific items.

    Time frame: Change from baseline to Week 12

  18. Cannabis Use Disorder Identification Test-Revised (CUDIT-R)

    The CUDIT-R is a self-report screening test that assesses cannabis use and related problems. It contains 8 items, 7 of which are rated on a 5-point scale ranging from 0 (never) to 4 (daily or almost daily), and 1 of which is rated on a 3-point scale from 0, 2 and 4. The total score ranges from 0-32, with higher scores indicating more hazardous cannabis use.

    Time frame: Change from baseline to Week 12

  19. Hoarding Rating Scale (HRS)

    The HRS will be administered as a self-report questionnaire to assess hoarding symptoms. It consists of 5 items rated on a 9-point scale from 0 (none) to 8 (extreme). The total scores range from 0-40, with greater scores indicating greater hoarding severity.

    Time frame: Change from baseline to Week 12

  20. Binge Eating Scale (BES)

    The BES is a self-report measure of behaviours, cognitions, and emotions related to binge eating. It consists of 16 items, 14 of which are rated on a 4-point scale from 0-3, and 2 of which are rated on a 3-point scale from 0-2. The total score ranges from 0-46, with higher scores indicating more severe binge eating problems.

    Time frame: Change from baseline to Week 12

  21. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a self-report questionnaire which measures sleep quality, patterns, and disturbances. It consists of 9 items, 4 of which are rated on a 4-point scale of 0 (not during the past month) to 3 (3 or more times a week), and 1 of which is rated on a 4 point scale of 0 (very good) to 3 (very bad). The other 4 questions collect information on sleep time and duration. The items are summed to produce 7 component scores ranging from 0-3, which are subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. These component scores are then combined to get the total score ranging from 0-21, with higher scores indicating worse sleep quality.

    Time frame: Change from baseline to Week 12

07

Study locations

1 site
  • MacAnxiety Research Center
    Hamilton, Ontario L8S 1B7, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Sep 2022, 41 months.

Of 44 non-industry phase 4 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 81. This study's 41 months is below that.

Counting every sponsor, half of 62 studies reached it within 38 months; a quarter within 18 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2018
First posted
Dec 24, 2018
StartActual
Apr 20, 2019
Primary completionActual
Sep 30, 2022
CompletionActual
Oct 31, 2022
Last update
Oct 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03785223
Lead sponsor
McMaster University
Collaborators
Purdue Pharma, Canada
Responsible party
Sponsor
First posted
Dec 24, 2018
Start date
Apr 20, 2019
Primary completion
Sep 30, 2022
Completion
Oct 31, 2022
Last update
Oct 26, 2023

Study contacts

Michael Van Ameringen, MD, FRCPC
principal investigator · McMaster University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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