Dextro-Amphetamine Versus Caffeine in Treatment-Resistant OCD
Information source: Stanford University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive-Compulsive Disorder
Intervention: dextro-amphetamine (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Stanford University Official(s) and/or principal investigator(s):
Lorrin M Koran, Principal Investigator, Affiliation: Stanford University
Summary
The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective
when used to augment treatment for OCD, and that tolerance (loss of therapeutic effect) to
the medication will not develop over a period of several weeks.
Clinical Details
Official title: Double-Blind Trial of Acute and Intermediate-Term Dextro-Amphetamine Versus Caffeine Augmentation in Treatment Resistant OCD
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Primary outcome: Yale-Brown Obsessive-Compulsive ScaleClinical Global Impressions Scale - Improvement
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 OCD, and whether
tolerance (loss of therapeutic effect) to the medication will develop over a period of
several weeks
D-amphetamine is FDA approved 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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria::
- outpatient age 18 through 55 inclusive
- DSM-IV criteria for obsessive-compulsive disorder (OCD)with YBOCS greater than or
equal to 20
- provide written informed consent
- no serious or unstable medical disorder, including no hypertension or cardiac disease
- not intending to receive psychotherapy for OCD during the study
- taking therapeutic dose of SSRI, venlafaxine, duloxetine, or clomipramine for at least
12 weeks
- if taking buspar, gabapentin, an atypical antipsychotic, or a benzodiazepine, dose has
been stable for 4 weeks
- negative urine drug and pregnancy tests Exclusion Criteria:- pregnant, breastfeeding,
not practicing reliable birth control method
- blood pressure readings greater than 140 mm Hg systolic or 90 mm Hg diastolic at
screen, or history of hypertension, whether or not it is controlled by medication
- hoarding is primary or only OCD symptom
- history of myocardial infarction or cardiac arrhythmia
- weight less than 100 lbs at screen
- requiring psychotropic medications other than an SRI, a benzodiazepine, buspirone, an
atypical antipsychotic, and/or gabapentin
- taking medication that inhibits hepatic enzyme CYP1a2 (e. g. Cipro)
- taking an MAO inhibitor
- comorbid tics or Tourette's disorder
- history of panic disorder
- history of glaucoma
- history of seizures
- schizophrenia or psychotic disorder, schizotypal personality disorder
- any depression with current suicide risk
- mental retardation, PDD, or cognitive disorder
- factitious disorders
- current or past cyclothymic disorder or bipolar disorder
- dissociative disorders
- personality disorder sufficient to interfere with study participation
- organic mental disorder or dementia
- current or past substance abuse / dependence (excluding nicotine)
- current or past anorexia or bulimia
- receiving psychotherapy for OCD
- had a previous trial of d-amphetamine of at least 30 days
- unable to speak, read, or understand English or unlikely to follow study procedures
- not suitable for study in investigator's opinion
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information
Starting date: August 2006
Last updated: April 24, 2008
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