Attention Deficit Hyperactivity DisorderPhase 3NCT00693212
Further Studies of Attention Deficit Disorder - Residual Type (RT)
A Phase 3 study testing methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by University of Utah at 1 site in United States.
Trial summary
The first phase was a double-blind crossover design of methylphenidate in the treatment of adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in adult ADHD. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1986to Nov 1994
- Phase
- Phase 3
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 21-55 years; male and female; met "Utah Criteria" for adult ADHD; 95th or higher percentile on the Parent Rating Scale and/or the Wender Utah Rating Scale;
Who cannot join
- Patients with other axis-I and axis-II diagnoses were excluded as were patients with significant medical problems.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Utah, School of Medicine, Mood Disorders Clinic
Salt Lake City, Utah, 84132
About this study
Official title: Further Studies of Attention Deficit Disorder - Residual Type
The first phase was a double-blind crossover design of methylphenidate in the treatment of adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in adult ADHD. It was hypothesized that methylphenidate would prove more effective than placebo in treating ADHD symptoms during the first phase. It was also hypothesized that methylphenidate responders from the double-blind trial would continue to benefit from treatment in the second phase. Improvement would include both ADHD symptoms and social adjustment.
Read the detailed description
All patients received a single-blind week on placebo, followed by a double-blind random assignment crossover trial of methylphenidate and placebo, with each double-blind phase lasting two weeks. Subjects who experienced moderate or marked improvement on methylphenidate would be allowed to enter a long-term, open-label trial. ADHD symptom severity was measured monthly by a structured interview, the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS), Clinical Global Impression - Improvement (CGI-I) and Global Assessment of Functioning (GAF). Social functioning was assessed by the clinician administered version of the Weissman Social Adjustment Scale (WSAS). Dosing was determined by clinical judgement, symptom improvement and AEs.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate, placebo
- Keywords
- ADHD, Adult, crossover, randomized, Long-term, Open-label, methylphenidate, Social adjustment
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidateDrug
Also called ritalin
Dosing was flexible and dependent on clinical judgement, AEs and treatment response.
methylphenidateDrug
Also called ritalin
Patients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day
placeboDrug
Dosing is identical to the MPH arm except that the pills will contain no active medication.
| Study group | Role | What they receive |
|---|---|---|
| a | Experimental | This arm was only open to subjects entering the second, open-label phase. All subjects were given open-label methylphenidate. Dosing was flexible. Receives: Drug: methylphenidate |
| MPH | Experimental | This is the active treatment arm of the double-blind placebo controlled phase. Patients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day Receives: Drug: methylphenidate |
| PBO | Placebo comparator | This 2 week arm is the placebo part of the crossover design. Subjects receive placebo in a manner similar to the MPH arm. It lasts 2 weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wender-Reimherr Adult Attention Deficit Disorder Scale
Measured: Monthly
Secondary outcomes (3)
Clinical Global Impression - Improvement
Measured: monthly
The Global Assessment of Functioning (GAF).
Measured: monthly
The Weissman Social Adjustment Scale (WSAS)
Measured: At termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startFeb 1986
- Primary completionNov 1994
- Study completionNov 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Paul H Wender, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693212
- Sponsor's protocol ID
- IRB 1491
- Status last verified
- Jun 2008
- First submitted
- 3 Jun 2008
- Last updated
- 6 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Further Studies of Attention Deficit Disorder - Residual Type
- ClinicalTrials.gov ID
- NCT00693212
- Acronym / sponsor ID
- IRB 1491
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Adult, crossover, randomized, Long-term, Open-label, methylphenidate, Social adjustment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 1986
- Primary completion
- Nov 1994 (actual)
- Study completion
- Nov 1994 (actual)
- First posted
- 6 Jun 2008 (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 first phase was a double-blind crossover design of methylphenidate in the treatment of adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in adult ADHD. It was hypothesized that methylphenidate would prove more effective than placebo in treating ADHD symptoms during the first phase. It was also hypothesized that methylphenidate responders from the double-blind trial would continue to benefit from treatment in the second phase. Improvement would include both ADHD symptoms and social adjustment.
Detailed description
All patients received a single-blind week on placebo, followed by a double-blind random assignment crossover trial of methylphenidate and placebo, with each double-blind phase lasting two weeks. Subjects who experienced moderate or marked improvement on methylphenidate would be allowed to enter a long-term, open-label trial. ADHD symptom severity was measured monthly by a structured interview, the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS), Clinical Global Impression - Improvement (CGI-I) and Global Assessment of Functioning (GAF). Social functioning was assessed by the clinician administered version of the Weissman Social Adjustment Scale (WSAS). Dosing was determined by clinical judgement, symptom improvement and AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| a | Experimental | Drug: methylphenidateThis arm was only open to subjects entering the second, open-label phase. All subjects were given open-label methylphenidate. Dosing was flexible. |
| MPH | Experimental | Drug: methylphenidateThis is the active treatment arm of the double-blind placebo controlled phase. Patients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day |
| PBO | Placebo comparator | Drug: placeboThis 2 week arm is the placebo part of the crossover design. Subjects receive placebo in a manner similar to the MPH arm. It lasts 2 weeks. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ages 21-55 years; male and female; met "Utah Criteria" for adult ADHD; 95th or higher percentile on the Parent Rating Scale and/or the Wender Utah Rating Scale;
Key exclusion criteria (1 listed)
- Patients with other axis-I and axis-II diagnoses were excluded as were patients with significant medical problems.
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 |
|---|---|---|
| methylphenidateAlso: ritalinDosing was flexible and dependent on clinical judgement, AEs and treatment response. | Drug | a |
| methylphenidateAlso: ritalinPatients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day | Drug | MPH |
| placeboDosing is identical to the MPH arm except that the pills will contain no active medication. | Drug | PBO |
Primary outcome
Wender-Reimherr Adult Attention Deficit Disorder Scale
Time frame: Monthly
3 secondary outcomes
Clinical Global Impression - Improvement
Time frame: monthly
The Global Assessment of Functioning (GAF).
Time frame: monthly
The Weissman Social Adjustment Scale (WSAS)
Time frame: At termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2008.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Paul H Wender, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by University of Utah at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jun 2008. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wender-Reimherr Adult Attention Deficit Disorder Scale (time frame: Monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2008.