Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Obsessive Compulsive Foundation
• Treatments: Amphetamine; Caffeine; Dextroamphetamine

Criteria

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