Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
Obsessive-Compulsive Disorder
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring D-amphetamine, dextro-amphetamine, stimulant drug
Eligibility 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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
d-amphetamine
Sham comparison
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
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