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Dextro-Amphetamine Versus Caffeine in Treatment-Resistant OCD
This study has been completed.
Study NCT00363298   Information provided by Stanford University
First Received: August 9, 2006   Last Updated: April 3, 2009   History of Changes

August 9, 2006
April 3, 2009
August 2006
March 2008   (final data collection date for primary outcome measure)
  • Clinical Global Impressions Scale - Improvement
  • Yale-Brown Obsessive-Compulsive Scale
  • Yale-Brown Obsessive-Compulsive Scale
  • Clinical Global Impressions Scale - Improvement
Complete list of historical versions of study NCT00363298 on ClinicalTrials.gov Archive Site
 
  • * Overall response rate
  • * Progression-free survival (PFS) and overall survival (OS)
  • * PFS and OS of patients who undergo autologous stem cell transplantation after induction therapy
 
Dextro-Amphetamine Versus Caffeine in Treatment-Resistant OCD
Double-Blind Trial of Acute and Intermediate-Term Dextro-Amphetamine Versus Caffeine Augmentation in Treatment Resistant OCD

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.

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.

 
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Obsessive-Compulsive Disorder
Drug: dextro-amphetamine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
24
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00363298
Lorrin M Koran, MD
97134
Stanford University
Obsessive Compulsive Foundation
Principal Investigator: Lorrin M Koran Stanford University
Stanford University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP