Status:
COMPLETED
Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Obsessive Compulsive Foundation
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
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 therapeut...
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 (...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00363298
Start Date
August 1 2006
End Date
March 1 2008
Last Update
March 28 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305