Clinical trial NCT00363298: Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
Official title: Double-blind Trial of Acute and Intermediate-term Dextro-amphetamine Versus Caffeine Augmentation in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: D-amphetamine, dextro-amphetamine, stimulant drug
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Obsessive Compulsive Foundation
First posted: 2006-08-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 therapeutic effect) to the medication will not develop over a period of several weeks.

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 (OCD), and whether tolerance (loss of therapeutic effect) to the medication will develop over a period of several weeks

D-amphetamine is approved by the U.S. Food and Drug Administration to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Because of the effects that d-amphetamine has on the brain, Dr. Koran believes it may be helpful in treating OCD. A positive finding in this study may stimulate research aimed at improving OCD treatment and understanding of the neurochemistry involved.

This research study will enroll 24 people who are taking medication for their OCD but are not receiving sufficient benefit. The research will be performed only at Stanford University.

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

Primary outcomes:
measure: Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2
timeFrame: At end of week 5, except 1 d-amphetamine subject rated at end of week 2
measure: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
timeFrame: At end of week 5, except 1 d-amphetamine subject rated at end of week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Lorrin M Koran
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koran LM, Aboujaoude E, Gamel NN. Double-blind study of dextroamphetamine versus caffeine augmentation for treatment-resistant obsessive-compulsive disorder. J Clin Psychiatry. 2009 Nov;70(11):1530-5. doi: 10.4088/JCP.08m04605. Epub 2009 Jun 30.