Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

This study has been completed.
Sponsor:
Collaborator:
Obsessive Compulsive Foundation
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University
ClinicalTrials.gov Identifier:
NCT00363298
First received: August 9, 2006
Last updated: June 5, 2012
Last verified: June 2012

August 9, 2006
June 5, 2012
August 2006
March 2008   (final data collection date for primary outcome measure)
  • Clinical Global Impressions Scale - Improvement [ Time Frame: last visit ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive-Compulsive Scale [ Time Frame: last visit ] [ Designated as safety issue: No ]
  • Clinical Global Impressions Scale - Improvement
  • Yale-Brown Obsessive-Compulsive Scale
Complete list of historical versions of study NCT00363298 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
Drug: dextro-amphetamine

dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.

Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.

Other Name: caffeine brand names: Vivarin, No-Dose
  • Experimental: d-amphetamine
    dextro-amphetamine capsules, 15 mg per capsule, in Bottles A and B, dose: one from Bottle A each morning and 1 from Bottle B each morning
    Intervention: Drug: dextro-amphetamine
  • Sham Comparator: caffeine pills
    caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules, dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning
    Intervention: Drug: dextro-amphetamine
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. Epub 2009 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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
97134
No
Lorrin M Koran, Stanford University
Stanford University
Obsessive Compulsive Foundation
Principal Investigator: Lorrin M Koran Stanford University
Stanford University
June 2012

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