We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: dextro-amphetamine Drug: Sham Comparison Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Trial of Acute and Intermediate-term Dextro-amphetamine Versus Caffeine Augmentation in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Study Start Date : August 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 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
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
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363298


Locations
Layout table for location information
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Obsessive Compulsive Foundation
Investigators
Layout table for investigator information
Principal Investigator: Lorrin M Koran Stanford University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Lorrin M Koran, Professor of Psychiatry, Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00363298    
Other Study ID Numbers: 97134
First Posted: August 15, 2006    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lorrin M Koran, Stanford University:
D-amphetamine, dextro-amphetamine, stimulant drug
Additional relevant MeSH terms:
Layout table for MeSH terms
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Caffeine
Amphetamine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors