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Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00363298
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
Obsessive Compulsive Foundation
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University

Tracking Information
First Submitted Date  ICMJE August 9, 2006
First Posted Date  ICMJE August 15, 2006
Results First Submitted Date  ICMJE April 20, 2015
Results First Posted Date  ICMJE March 28, 2017
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE August 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2 [ Time Frame: At end of week 5, except 1 d-amphetamine subject rated at end of week 2 ]
    Clinical Global Impressions Scale Improvement Score = 1 (very much improved), or 2 (much improved). Additional possible scale scores are 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse).
  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score [ Time Frame: At end of week 5, except 1 d-amphetamine subject rated at end of week 2 ]
    Yale-Brown Obsessive-Compulsive Scale score by blinded investigator in direct interview. The scale score is the sum of ten items (5 for obsessions and 5 for compulsions: time occupied, degree of interference with functioning, degree of distress, effort to resist the symptom, success in resisting), each rated from 0 to 4, with higher scores indicating more severe OCD. Maximum score is 40. Scores of 14 and below are often described as "subclinical," though patients with these scores may still exhibit troubling symptoms and mild to moderate distress. A total score of 8 or less is often termed "remission." A decrease in total score from baseline to endpoint of either 25% or 35% is often used as a "responder" criterion in clinical trials.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2006)
  • Yale-Brown Obsessive-Compulsive Scale
  • Clinical Global Impressions Scale - Improvement
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
Official Title  ICMJE Double-blind Trial of Acute and Intermediate-term Dextro-amphetamine Versus Caffeine Augmentation in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Brief Summary The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and that tolerance (loss of therapeutic effect) to the medication will not develop over a period of several weeks.
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 Obsessive-Compulsive Disorder (OCD), and whether tolerance (loss of therapeutic effect) to the medication will develop over a period of several weeks

D-amphetamine is approved by the U.S. Food and Drug Administration 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • 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.
    Other Name: Dexedrine
  • Drug: Sham Comparison
    caffeine dosage form: capsules identical to those in dextro-amphetamine arm, but containing 200 mg caffeine in Bottle A and 100 mg caffeine in Bottle B. Frequency: once daily. Duration: 5 weeks
    Other Name: Caffeine, 300 mg/day
Study Arms  ICMJE
  • 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: Sham comparison
    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: Sham Comparison
Publications * 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. doi: 10.4088/JCP.08m04605. Epub 2009 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2006)
24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • outpatient age 18 through 55 inclusive
  • meets DSM-IV criteria for obsessive-compulsive disorder (OCD) with Yale-Brown Obsessive-Compulsive Scale (YBOCS) score greater than or equal to 20
  • provides written informed consent
  • has taken for at least 12 weeks at least the dose shown of a selective serotonin reuptake inhibitor (SSRI) [citalopram, escitalopram, or fluoxetine 20 mg/d; paroxetine 40 mg/d; sertraline 50 mg/d]; or venlafaxine 225 mg/d; or duloxetine 60 mg/d.
  • if taking buspar, gabapentin, an atypical antipsychotic, or a benzodiazepine, dose has been stable for 4 weeks
  • has negative urine drug and pregnancy tests
  • is practicing reliable birth control method
  • has blood pressure readings at screening visit that are less than 140 mm Hg systolic and 90 mm Hg diastolic,
  • weight is greater than 100 lbs at screen

Exclusion criteria:

  • requires psychotropic medications other than an Serotonin Reuptake Inhibitor (SRI), a benzodiazepine, buspirone, an atypical antipsychotic, and/or gabapentin
  • is taking clomipramine
  • is taking fluvoxamine
  • is taking medication that inhibits hepatic enzyme CYP1A2
  • is taking a monoamine oxidase inhibitor
  • has co-morbid tics or Tourette's disorder
  • has hoarding as the primary or only OCD symptom
  • has a history of panic disorder
  • has a history of glaucoma
  • has a history of seizures
  • has a history of schizophrenia or psychotic disorder, or schizotypal personality disorder
  • has depression with current suicide risk
  • has mental retardation, pervasive developmental disorder, or cognitive disorder
  • has a factitious disorder
  • has current or past cyclothymic disorder or bipolar disorder
  • has a dissociative disorder
  • has personality disorder sufficient to interfere with study participation
  • has organic mental disorder or dementia
  • has current or past substance abuse / dependence (excluding nicotine)
  • has current or past anorexia or bulimia
  • has serious or unstable medical disorder, including hypertension or cardiac disease
  • has history of myocardial infarction or cardiac arrhythmia
  • has history of or has current diagnosis of hypertension
  • is pregnant or breast-feeding
  • is receiving psychotherapy for OCD
  • is intending to receive psychotherapy for OCD during the study
  • has had a previous trial of d-amphetamine of at least 30 days duration
  • is unable to speak, read, or understand English
  • is not likely to follow study procedures
  • is not suitable for study in the investigator's opinion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00363298
Other Study ID Numbers  ICMJE 97134
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lorrin M Koran, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Obsessive Compulsive Foundation
Investigators  ICMJE
Principal Investigator: Lorrin M Koran Stanford University
PRS Account Stanford University
Verification Date February 2017

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