Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Double-blind Trial of Acute and Intermediate-term Dextro-amphetamine Versus Caffeine Augmentation in Treatment Resistant OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363298
• Other study ID #: 97134
• Status: Completed
• Phase: N/A
• First received: August 9, 2006
• Last updated: June 5, 2012
• Start date: August 2006
• Est. completion date: March 2008

Study information

• Verified date: June 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Obsessive Compulsive Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impressions Scale - Improvement		last visit	No
Primary	Yale-Brown Obsessive-Compulsive Scale		last visit	No