Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

Not Applicable

Completed

Conditions: Obsessive-Compulsive Disorder

Interventions: Drug: dextro-amphetamine
Drug: Sham Comparison

Registration Number: NCT00363298

Lead Sponsor: Stanford University

Brief Summary: The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and that tolerance (loss of therapeutic effect) to the medication will not develop over a period of several weeks.

Detailed Description: The study will investigate whether dextro-amphetamine (d-amphetamine) is safe and effective compared to caffeine as an active placebo when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and whether tolerance (loss of therapeutic effect) to the medication will develop over a period of several weeks

D-amphetamine is approved by the U.S. Food and Drug Administration to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Because of the effects that d-amphetamine has on the brain, Dr. Koran believes it may be helpful in treating OCD. A positive finding in this study may stimulate research aimed at improving OCD treatment and understanding of the neurochemistry involved.

This research study will enroll 24 people who are taking medication for their OCD but are not receiving sufficient benefit. The research will be performed only at Stanford University.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

outpatient age 18 through 55 inclusive
meets DSM-IV criteria for obsessive-compulsive disorder (OCD) with Yale-Brown Obsessive-Compulsive Scale (YBOCS) score greater than or equal to 20
provides written informed consent
has taken for at least 12 weeks at least the dose shown of a selective serotonin reuptake inhibitor (SSRI) [citalopram, escitalopram, or fluoxetine 20 mg/d; paroxetine 40 mg/d; sertraline 50 mg/d]; or venlafaxine 225 mg/d; or duloxetine 60 mg/d.
if taking buspar, gabapentin, an atypical antipsychotic, or a benzodiazepine, dose has been stable for 4 weeks
has negative urine drug and pregnancy tests
is practicing reliable birth control method
has blood pressure readings at screening visit that are less than 140 mm Hg systolic and 90 mm Hg diastolic,
weight is greater than 100 lbs at screen

Exclusion criteria:

requires psychotropic medications other than an Serotonin Reuptake Inhibitor (SRI), a benzodiazepine, buspirone, an atypical antipsychotic, and/or gabapentin
is taking clomipramine
is taking fluvoxamine
is taking medication that inhibits hepatic enzyme CYP1A2
is taking a monoamine oxidase inhibitor
has co-morbid tics or Tourette's disorder
has hoarding as the primary or only OCD symptom
has a history of panic disorder
has a history of glaucoma
has a history of seizures
has a history of schizophrenia or psychotic disorder, or schizotypal personality disorder
has depression with current suicide risk
has mental retardation, pervasive developmental disorder, or cognitive disorder
has a factitious disorder
has current or past cyclothymic disorder or bipolar disorder
has a dissociative disorder
has personality disorder sufficient to interfere with study participation
has organic mental disorder or dementia
has current or past substance abuse / dependence (excluding nicotine)
has current or past anorexia or bulimia
has serious or unstable medical disorder, including hypertension or cardiac disease
has history of myocardial infarction or cardiac arrhythmia
has history of or has current diagnosis of hypertension
is pregnant or breast-feeding
is receiving psychotherapy for OCD
is intending to receive psychotherapy for OCD during the study
has had a previous trial of d-amphetamine of at least 30 days duration
is unable to speak, read, or understand English
is not likely to follow study procedures
is not suitable for study in the investigator's opinion

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
d-amphetamine	dextro-amphetamine	dextro-amphetamine capsules, 15 mg per capsule, in Bottles A and B, dose: one from Bottle A each morning and 1 from Bottle B each morning
Sham comparison	Sham Comparison	caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules, dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2	At end of week 5, except 1 d-amphetamine subject rated at end of week 2	Clinical Global Impressions Scale Improvement Score = 1 (very much improved), or 2 (much improved). Additional possible scale scores are 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse).
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score	At end of week 5, except 1 d-amphetamine subject rated at end of week 2	Yale-Brown Obsessive-Compulsive Scale score by blinded investigator in direct interview. The scale score is the sum of ten items (5 for obsessions and 5 for compulsions: time occupied, degree of interference with functioning, degree of distress, effort to resist the symptom, success in resisting), each rated from 0 to 4, with higher scores indicating more severe OCD. Maximum score is 40. Scores of 14 and below are often described as "subclinical," though patients with these scores may still exhibit troubling symptoms and mild to moderate distress. A total score of 8 or less is often termed "remission." A decrease in total score from baseline to endpoint of either 25% or 35% is often used as a "responder" criterion in clinical trials.

Secondary Outcome Measures