Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
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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 |
- 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 |
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| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| 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:
|
Obsessive-Compulsive Disorder Compulsive Personality Disorder Anxiety Disorders Mental Disorders Personality 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 June 18, 2013