ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Dextro-Amphetamine Versus Caffeine in Treatment-Resistant OCD

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Stanford University
Obsessive Compulsive Foundation
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00363298
  Purpose

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.


Condition Intervention
Obsessive-Compulsive Disorder
Drug: dextro-amphetamine

MedlinePlus related topics:   Caffeine    Obsessive-Compulsive Disorder   

ChemIDplus related topics:   Dextroamphetamine    Dextroamphetamine sulfate    Amphetamine    Amphetamine sulfate    3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione    Caffeine citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:   Double-Blind Trial of Acute and Intermediate-Term Dextro-Amphetamine Versus Caffeine Augmentation in Treatment Resistant OCD

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Scale
  • Clinical Global Impressions Scale - Improvement

Estimated Enrollment:   24
Study Start Date:   August 2006

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 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.

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

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


Study ID Numbers:   97134
First Received:   August 9, 2006
Last Updated:   April 24, 2008
ClinicalTrials.gov Identifier:   NCT00363298
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Caffeine citrate
Dopamine
Anxiety Disorders
Mental Disorders
Dextroamphetamine
Caffeine
Amphetamine
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers