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Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
Not Recruiting
Trial ID: NCT00363298
Purpose
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.
Official Title
Double-blind Trial of Acute and Intermediate-term Dextro-amphetamine Versus Caffeine Augmentation in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Stanford Investigator(s)
Eligibility
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
Intervention(s):
drug: dextro-amphetamine
drug: Sham Comparison
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lorrin Koran
6507235154