N/A
N=24
Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
Obsessive-Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00363298 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2 — 6; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- dextro-amphetamine (Drug); Sham Comparison (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2 |
6; 7 | — |
| PRIMARY Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score |
13.3; 13.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00363298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.