Overview

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