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Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dextro-amphetamine
Sham Comparison
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring D-amphetamine, dextro-amphetamine, stimulant drug

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

d-amphetamine

Sham comparison

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2
Clinical Global Impressions Scale Improvement Score = 1 (very much improved), or 2 (much improved). Additional possible scale scores are 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse).
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
Yale-Brown Obsessive-Compulsive Scale score by blinded investigator in direct interview. The scale score is the sum of ten items (5 for obsessions and 5 for compulsions: time occupied, degree of interference with functioning, degree of distress, effort to resist the symptom, success in resisting), each rated from 0 to 4, with higher scores indicating more severe OCD. Maximum score is 40. Scores of 14 and below are often described as "subclinical," though patients with these scores may still exhibit troubling symptoms and mild to moderate distress. A total score of 8 or less is often termed "remission." A decrease in total score from baseline to endpoint of either 25% or 35% is often used as a "responder" criterion in clinical trials.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2006
Last Updated
February 7, 2017
Sponsor
Stanford University
Collaborators
Obsessive Compulsive Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00363298
Brief Title
Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
Official Title
Double-blind Trial of Acute and Intermediate-term Dextro-amphetamine Versus Caffeine Augmentation in Treatment Resistant Obsessive Compulsive Disorder (OCD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Obsessive Compulsive Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
D-amphetamine, dextro-amphetamine, stimulant drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
d-amphetamine
Arm Type
Experimental
Arm Description
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
Arm Title
Sham comparison
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
dextro-amphetamine
Other Intervention Name(s)
Dexedrine
Intervention Description
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
Intervention Name(s)
Sham Comparison
Other Intervention Name(s)
Caffeine, 300 mg/day
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2
Description
Clinical Global Impressions Scale Improvement Score = 1 (very much improved), or 2 (much improved). Additional possible scale scores are 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse).
Time Frame
At end of week 5, except 1 d-amphetamine subject rated at end of week 2
Title
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
Description
Yale-Brown Obsessive-Compulsive Scale score by blinded investigator in direct interview. The scale score is the sum of ten items (5 for obsessions and 5 for compulsions: time occupied, degree of interference with functioning, degree of distress, effort to resist the symptom, success in resisting), each rated from 0 to 4, with higher scores indicating more severe OCD. Maximum score is 40. Scores of 14 and below are often described as "subclinical," though patients with these scores may still exhibit troubling symptoms and mild to moderate distress. A total score of 8 or less is often termed "remission." A decrease in total score from baseline to endpoint of either 25% or 35% is often used as a "responder" criterion in clinical trials.
Time Frame
At end of week 5, except 1 d-amphetamine subject rated at end of week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorrin M Koran
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19573497
Citation
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.
Results Reference
result

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Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

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