Further Studies of Attention Deficit Disorder - Residual Type (RT)

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: placebo; Drug: methylphenidate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00693212

IRB 1491

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;

Exclusion criteria

• Patients with other axis-I and axis-II diagnoses were excluded as were patients with significant medical problems.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

116 participants in 3 patient groups, including a placebo group

a

Experimental group

Description:

This arm was only open to subjects entering the second, open-label phase. All subjects were given open-label methylphenidate. Dosing was flexible.

Treatment:

Drug: methylphenidate

Drug: methylphenidate

MPH

Experimental group

Description:

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

Treatment:

Drug: methylphenidate

Drug: methylphenidate

PBO

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo