Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

NCT ID: NCT00363298

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-03-31

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

dextro-amphetamine

Intervention Type: DRUG

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.

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

Group Type: SHAM_COMPARATOR

Sham Comparison

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Dexedrine; Caffeine, 300 mg/day

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Obsessive Compulsive Foundation

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Lorrin M Koran

Professor of Psychiatry, Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorrin M Koran

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19573497 (View on PubMed)

Other Identifiers

97134

Identifier Type: -

Identifier Source: org_study_id