Dextro-Amphetamine Versus Caffeine in Treatment-Resistant OCD - Full Text View

Sponsor:	Stanford University
Collaborator:	Obsessive Compulsive Foundation
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00363298

Purpose

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.

Condition	Intervention
Obsessive-Compulsive Disorder	Drug: dextro-amphetamine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Double-Blind Trial of Acute and Intermediate-Term Dextro-Amphetamine Versus Caffeine Augmentation in Treatment Resistant OCD

Resource links provided by NLM:

MedlinePlus related topics: Caffeine Methamphetamine Obsessive-Compulsive Disorder

Drug Information available for: Methamphetamine hydrochloride Dextroamphetamine sulfate Dextroamphetamine Amphetamine sulfate Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Clinical Global Impressions Scale - Improvement
Yale-Brown Obsessive-Compulsive Scale

Enrollment:	24
Study Start Date:	August 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363298

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Obsessive Compulsive Foundation

Investigators

Principal Investigator:

Lorrin M Koran

Stanford University

More Information

No publications provided

Responsible Party:	( Lorrin M Koran, MD )
Study ID Numbers:	97134
Study First Received:	August 9, 2006
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00363298 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Methamphetamine

Anxiety Disorders
Mental Disorders
Autonomic Agents
Dextroamphetamine
Therapeutic Uses
Dopamine Agents
Amphetamine
Peripheral Nervous System Agents
Central Nervous System Agents
Obsessive-Compulsive Disorder

ClinicalTrials.gov processed this record on November 27, 2009