Attention Deficit Hyperactivity DisorderNCT02210728
Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder
A study testing methylphenidate or amphetamine product and Cognitive behavioral therapy in people with Attention Deficit Hyperactivity Disorder, run by Lily Hechtman at 1 site in Canada.
Trial summary
The purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (CBT) for adults with attention deficit hyperactivity disorder (ADHD) with and without stimulant medication and compare it to medication alone. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- methylphenidate or amphetamine product and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for adult ADHD of any of three subtypes via Conners' Adult ADHD Diagnostic Interview for the DSM-IV (CAAR-D) and clinician's assessment;
- Barkley Childhood and Current Symptom of ADHD (1998) completed by self and informants (parents or siblings). Required cut off's on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
- Conners' Adult ADHD Rating Scale (1999). Required cut off's on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
- Between 18 and 60 years old
- Be able to give informed consent and comply with study procedures;
- I.Q. of 80 or above on Wechsler Adult Intelligence Scale, 3rd edition (WAIS-III) subtests of three verbal and three nonverbal subtests
- Adequate command of English to be able to participate in CBT group.
Who cannot join
- Psychotic symptoms, past or current
- Current psychiatric comorbidity, e.g. bipolar disorder, depression, suicidality, current substance use disorder (must be free of substance abuse for 6 months)
- Medical condition that preclude use of the stimulant medication, e.g. hypertension, cardiac disease, Tourette's Syndrome, etc.
- Organic mental disorders or other significant neurological disorders, e.g. epilepsy, head injury, chorea, multiple sclerosis, deafness, blindness.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (CBT) for adults with attention deficit hyperactivity disorder (ADHD) with and without stimulant medication and compare it to medication alone. Subjects will be randomly assigned to stimulant medication only, CBT only and combined CBT and stimulant medication group. Patients will be evaluated at baseline, following mediation optimization (for medicated groups), following 12 months of treatment, after 3 months of follow up, and after 6 months of follow up. The investigators hypothesize that the combined group will have the best outcome at all evaluation points. ADHD in adults is associated with significant morbidity and impaired academic, occupational, social, and emotional functioning. Developing optimal treatment approaches for this population is key in improving their functioning.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate or amphetamine product, Cognitive behavioral therapy
- Keywords
- cognitive behavioral therapy, stimulant medication, efficacy, symptoms, functional outcomes
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidate or amphetamine productDrug
Also called Ritalin, Concerta, Biphentin, Dexedrine
Medication is titrated over a 4-week period with stepwise increments each week. Patients and significant others complete ADHD symptom scales at baseline and before each medication visit. Patients also complete side effects scales at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the subjects remain on this dose for the remainder of the study.
Cognitive behavioral therapyBehavioural
12 sessions of group cognitive behavioral therapy. Participants also receive individual coaching 3 times a week (twice over telephone and once in person). Coaching sessions are 15 minutes each in duration and are aimed at implementation, practice, and generalization of skills acquired in therapy.
| Study group | Role | What they receive |
|---|---|---|
| Medication only | Active comparator | Stimulant medication (methylphenidate or amphetamine product approved for clinical use in Canada), with dose optimized for each patient based on report of efficacy and side effects. Receives: Drug: methylphenidate or amphetamine product |
| Cognitive behavioral therapy + medication | Active comparator | Patients are first titrated to an optimal dose of stimulant medication. They then undergo the 12 weeks of group cognitive behavioral therapy. Receives: Drug: methylphenidate or amphetamine product; Behavioral: Cognitive behavioral therapy |
| Cognitive behavioral therapy alone | Experimental | 12 weeks of structured group cognitive behavioral therapy, focusing on acquisition of skills in organization, time management, goal attainment, cognitive restructuring, stress management, anger management, impulse control, self-esteem, and relationship management. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline
Measured: At baseline
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
Measured: For patients in a medication or combined group - after medication has been optimally titrated, approximately 5 weeks.
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
Measured: After 12 weeks of Cognitive Behavioural Therapy
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
Measured: Three months after the end of Cognitive Behavioural Therapy
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
Measured: Six months after the end of Cognitive Behavioural Therapy
Secondary outcomes (9)
Global psychological distress (measured via the Symptom Checklist 90) - Change from baseline
Measured: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Depression symptoms (via the Beck Depression Inventory) - Change from baseline
Measured: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Anxiety symptoms (measured via the Beck Anxiety Inventory) - Change from baseline
Measured: At baseline; once optimally titrated, approximately 5 weeks (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline
Measured: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline
Measured: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Organizational skills (measured via the Organization and Activation for Work Scale) - Change from baseline
Measured: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Self-esteem (measured via the Index of Self-Esteem) - Change from baseline
Measured: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Anger Expression (measured via the State Trait Anger Expression Inventory - II) - Change from baseline
Measured: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Observer-Rated ADHD symptoms (measured via the Barkley's Current ADHD Symptoms Scale -- observer version) - Change from baseline
Measured: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startApr 2006
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lily Hechtman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lily Hechtman, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Lily Hechtman, MD, FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210728
- Sponsor's protocol ID
- PED-06-002
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kessler RC, Adler L, Barkley R, Biederman J, Conners CK, Demler O, Faraone SV, Greenhill LL, Howes MJ, Secnik K, Spencer T, Ustun TB, Walters EE, Zaslavsky AM. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Apr;163(4):716-23. doi: 10.1176/ajp.2006.163.4.716.
PubMed 16585449Safren SA. Cognitive-behavioral approaches to ADHD treatment in adulthood. J Clin Psychiatry. 2006;67 Suppl 8:46-50.
PubMed 16961430Wilens TE, Spencer TJ, Biederman J. A review of the pharmacotherapy of adults with attention-deficit/hyperactivity disorder. J Atten Disord. 2002 Mar;5(4):189-202. doi: 10.1177/108705470100500401.
PubMed 11967475Bramham J, Young S, Bickerdike A, Spain D, McCartan D, Xenitidis K. Evaluation of group cognitive behavioral therapy for adults with ADHD. J Atten Disord. 2009 Mar;12(5):434-41. doi: 10.1177/1087054708314596. Epub 2008 Feb 29.
PubMed 18310557Gualtieri CT, Ondrusek MG, Finley C. Attention deficit disorders in adults. Clin Neuropharmacol. 1985;8(4):343-56. doi: 10.1097/00002826-198512000-00005.
PubMed 4075304Knouse LE, Cooper-Vince C, Sprich S, Safren SA. Recent developments in the psychosocial treatment of adult ADHD. Expert Rev Neurother. 2008 Oct;8(10):1537-48. doi: 10.1586/14737175.8.10.1537.
PubMed 18928346Mattes JA, Boswell L, Oliver H. Methylphenidate effects on symptoms of attention deficit disorder in adults. Arch Gen Psychiatry. 1984 Nov;41(11):1059-63. doi: 10.1001/archpsyc.1983.01790220049008.
PubMed 6388523Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.
PubMed 20736471Solanto MV, Marks DJ, Wasserstein J, Mitchell K, Abikoff H, Alvir JM, Kofman MD. Efficacy of meta-cognitive therapy for adult ADHD. Am J Psychiatry. 2010 Aug;167(8):958-68. doi: 10.1176/appi.ajp.2009.09081123. Epub 2010 Mar 15.
PubMed 20231319Spencer T, Biederman J, Wilens T, Doyle R, Surman C, Prince J, Mick E, Aleardi M, Herzig K, Faraone S. A large, double-blind, randomized clinical trial of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2005 Mar 1;57(5):456-63. doi: 10.1016/j.biopsych.2004.11.043.
PubMed 15737659Weiss, G., & Hechtman, L. (1993). Hyperactive children grown up : ADHD in children, adolescents, and adults (2nd ed.). New York: Guilford Press.
Barkley, R. A., Murphy, K. R., & Firscher, M. (2008). ADHD in adults: What the Science Says. New York: Guilford Press
Hechtman, L., Treatment of adults with adhd: Cbt only versus medication and cbt, in Third International Congress on ADHD - From Childhood to Adolescence. 2011: Berlin, Germany.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02210728
- Acronym / sponsor ID
- PED-06-002
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- cognitive behavioral therapy, stimulant medication, efficacy, symptoms, functional outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lily HechtmanUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (CBT) for adults with attention deficit hyperactivity disorder (ADHD) with and without stimulant medication and compare it to medication alone. Subjects will be randomly assigned to stimulant medication only, CBT only and combined CBT and stimulant medication group. Patients will be evaluated at baseline, following mediation optimization (for medicated groups), following 12 months of treatment, after 3 months of follow up, and after 6 months of follow up. The investigators hypothesize that the combined group will have the best outcome at all evaluation points. ADHD in adults is associated with significant morbidity and impaired academic, occupational, social, and emotional functioning. Developing optimal treatment approaches for this population is key in improving their functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medication only | Active comparator | Drug: methylphenidate or amphetamine productStimulant medication (methylphenidate or amphetamine product approved for clinical use in Canada), with dose optimized for each patient based on report of efficacy and side effects. |
| Cognitive behavioral therapy + medication | Active comparator | Drug: methylphenidate or amphetamine product, Behavioral: Cognitive behavioral therapyPatients are first titrated to an optimal dose of stimulant medication. They then undergo the 12 weeks of group cognitive behavioral therapy. |
| Cognitive behavioral therapy alone | Experimental | Behavioral: Cognitive behavioral therapy12 weeks of structured group cognitive behavioral therapy, focusing on acquisition of skills in organization, time management, goal attainment, cognitive restructuring, stress management, anger management, impulse control, self-esteem, and relationship management. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for adult ADHD of any of three subtypes via Conners' Adult ADHD Diagnostic Interview for the DSM-IV (CAAR-D) and clinician's assessment;
- Barkley Childhood and Current Symptom of ADHD (1998) completed by self and informants (parents or siblings). Required cut off's on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
- Conners' Adult ADHD Rating Scale (1999). Required cut off's on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
- Between 18 and 60 years old
- Be able to give informed consent and comply with study procedures;
Key exclusion criteria (4 listed)
- Psychotic symptoms, past or current
- Current psychiatric comorbidity, e.g. bipolar disorder, depression, suicidality, current substance use disorder (must be free of substance abuse for 6 months)
- Medical condition that preclude use of the stimulant medication, e.g. hypertension, cardiac disease, Tourette's Syndrome, etc.
- Organic mental disorders or other significant neurological disorders, e.g. epilepsy, head injury, chorea, multiple sclerosis, deafness, blindness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate or amphetamine productAlso: Ritalin, Concerta, Biphentin, DexedrineMedication is titrated over a 4-week period with stepwise increments each week. Patients and significant others complete ADHD symptom scales at baseline and before each medication visit. Patients also complete side effects scales at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the subjects remain on this dose for the remainder of the study. | Drug | Cognitive behavioral therapy + medication, Medication only |
| Cognitive behavioral therapy12 sessions of group cognitive behavioral therapy. Participants also receive individual coaching 3 times a week (twice over telephone and once in person). Coaching sessions are 15 minutes each in duration and are aimed at implementation, practice, and generalization of skills acquired in therapy. | Behavioural | Cognitive behavioral therapy + medication, Cognitive behavioral therapy alone |
Primary outcome
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline
Time frame: At baseline
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
Time frame: For patients in a medication or combined group - after medication has been optimally titrated, approximately 5 weeks.
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
Time frame: After 12 weeks of Cognitive Behavioural Therapy
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
Time frame: Three months after the end of Cognitive Behavioural Therapy
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
Time frame: Six months after the end of Cognitive Behavioural Therapy
9 secondary outcomes
Global psychological distress (measured via the Symptom Checklist 90) - Change from baseline
Time frame: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Depression symptoms (via the Beck Depression Inventory) - Change from baseline
Time frame: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Anxiety symptoms (measured via the Beck Anxiety Inventory) - Change from baseline
Time frame: At baseline; once optimally titrated, approximately 5 weeks (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline
Time frame: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline
Time frame: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Organizational skills (measured via the Organization and Activation for Work Scale) - Change from baseline
Time frame: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Self-esteem (measured via the Index of Self-Esteem) - Change from baseline
Time frame: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Anger Expression (measured via the State Trait Anger Expression Inventory - II) - Change from baseline
Time frame: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Observer-Rated ADHD symptoms (measured via the Barkley's Current ADHD Symptoms Scale -- observer version) - Change from baseline
Time frame: At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Background: PubMed 16585449Kessler RC, Adler L, Barkley R, Biederman J, Conners CK, Demler O, Faraone SV, Greenhill LL, Howes MJ, Secnik K, Spencer T, Ustun TB, Walters EE, Zaslavsky AM. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Apr;163(4):716-23. doi: 10.1176/ajp.2006.163.4.716.
- Background: PubMed 16961430Safren SA. Cognitive-behavioral approaches to ADHD treatment in adulthood. J Clin Psychiatry. 2006;67 Suppl 8:46-50.
- Background: PubMed 11967475Wilens TE, Spencer TJ, Biederman J. A review of the pharmacotherapy of adults with attention-deficit/hyperactivity disorder. J Atten Disord. 2002 Mar;5(4):189-202. doi: 10.1177/108705470100500401.
- Background: PubMed 18310557Bramham J, Young S, Bickerdike A, Spain D, McCartan D, Xenitidis K. Evaluation of group cognitive behavioral therapy for adults with ADHD. J Atten Disord. 2009 Mar;12(5):434-41. doi: 10.1177/1087054708314596. Epub 2008 Feb 29.
- Background: PubMed 4075304Gualtieri CT, Ondrusek MG, Finley C. Attention deficit disorders in adults. Clin Neuropharmacol. 1985;8(4):343-56. doi: 10.1097/00002826-198512000-00005.
- Background: PubMed 18928346Knouse LE, Cooper-Vince C, Sprich S, Safren SA. Recent developments in the psychosocial treatment of adult ADHD. Expert Rev Neurother. 2008 Oct;8(10):1537-48. doi: 10.1586/14737175.8.10.1537.
- Background: PubMed 6388523Mattes JA, Boswell L, Oliver H. Methylphenidate effects on symptoms of attention deficit disorder in adults. Arch Gen Psychiatry. 1984 Nov;41(11):1059-63. doi: 10.1001/archpsyc.1983.01790220049008.
- Background: PubMed 20736471Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.
- Background: PubMed 20231319Solanto MV, Marks DJ, Wasserstein J, Mitchell K, Abikoff H, Alvir JM, Kofman MD. Efficacy of meta-cognitive therapy for adult ADHD. Am J Psychiatry. 2010 Aug;167(8):958-68. doi: 10.1176/appi.ajp.2009.09081123. Epub 2010 Mar 15.
- Background: PubMed 15737659Spencer T, Biederman J, Wilens T, Doyle R, Surman C, Prince J, Mick E, Aleardi M, Herzig K, Faraone S. A large, double-blind, randomized clinical trial of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2005 Mar 1;57(5):456-63. doi: 10.1016/j.biopsych.2004.11.043.
- BackgroundWeiss, G., & Hechtman, L. (1993). Hyperactive children grown up : ADHD in children, adolescents, and adults (2nd ed.). New York: Guilford Press.
- BackgroundBarkley, R. A., Murphy, K. R., & Firscher, M. (2008). ADHD in adults: What the Science Says. New York: Guilford Press
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lily Hechtman, MD, FRCPC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylphenidate or amphetamine product and Cognitive behavioral therapy in people with Attention Deficit Hyperactivity Disorder, run by Lily Hechtman at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02210728, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.