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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: February 7, 2017
Last verified: February 2017
  Purpose
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 Intervention
Obsessive-Compulsive Disorder Drug: dextro-amphetamine Drug: Sham Comparison

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Lorrin M Koran, Stanford University:

Primary Outcome Measures:
  • 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.


Enrollment: 24
Study Start Date: August 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363298

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Obsessive Compulsive Foundation
Investigators
Principal Investigator: Lorrin M Koran Stanford University
  More Information

Publications:
Responsible Party: Lorrin M Koran, Professor of Psychiatry, Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00363298     History of Changes
Other Study ID Numbers: 97134
Study First Received: August 9, 2006
Results First Received: April 20, 2015
Last Updated: February 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Lorrin M Koran, Stanford University:
D-amphetamine, dextro-amphetamine, stimulant drug

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior
Caffeine
Dextroamphetamine
Amphetamine
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
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017