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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Trial of Acute and Intermediate-term Dextro-amphetamine Versus Caffeine Augmentation in Treatment Resistant OCD

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

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.

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
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
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

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
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
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Amphetamine
Caffeine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

ClinicalTrials.gov processed this record on October 01, 2014