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Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

Information source: Stanford University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obsessive-Compulsive Disorder

Intervention: dextro-amphetamine (Drug)

Phase: N/A

Status: Completed

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Clinical Global Impressions Scale - Improvement

Yale-Brown Obsessive-Compulsive Scale

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: June 5, 2012

Page last updated: August 20, 2015

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