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| Name | Class |
|---|---|
| Obsessive Compulsive Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| d-amphetamine | Experimental | 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 |
|
| Sham comparison | Sham Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dextro-amphetamine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At end of week 5, except 1 d-amphetamine subject rated at end of week 2 |
| 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. | At end of week 5, except 1 d-amphetamine subject rated at end of week 2 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorrin M Koran | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19573497 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | D-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. |
| FG001 | 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. Frequency: once daily. Duration: 5 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Study Week |
|
| ||||||||||||||||||
| 4-week Study Continuation Phase |
|
24 Subjects meeting the listed entry criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | D-amphetamine | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean Age, and standard deviation, in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Subjects who met the study continuation phase entry criterion of >20% decrease in Y-BOCS score after 1 week of double-blind study medication, and entered this 4-week double-blind continuation phase | Posted | Number | participants | At end of week 5, except 1 d-amphetamine subject rated at end of week 2 |
|
1 week for 11 subjects who did not meet entry criteria for the 4-week extension phase, 2 weeks for the single subject who discontinued in week 2 for lack of efficacy and 5 weeks for the 12 subjects who completed the extension phase.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| insomnia | Psychiatric disorders | Non-systematic Assessment |
Modest sample size of 24 subjects, 12 in each drug group. Observation period was only 5 weeks long.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lorrin M. Koran, M.D. | Stanford University Medical Center, Department of Psychiatry | 650 498-5035 | lkoran@stanford.edu |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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|
| Sham Comparison | 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 |
|
|
| NOT COMPLETED |
|
|
| BG001 | 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. Frequency: once daily. Duration: 5 weeks |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Prior Selective Serotonin Reuptake or Serotonin Norepinephrine Reuptake Inhibitor trials | Mean | Standard Deviation | trials |
|
| Atypical antipsychotic drug augmentation trials | Mean | Standard Deviation | trials |
|
| OG001 | 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. Frequency: once daily. Duration: 5 weeks |
|
|
| Primary | 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. | Subjects who entered the 4-week double-blind study continuation phase, including a last observation carried forward for the one d-amphetamine subject who dropped out of this phase at the end of study week 2 (end of the first week of the continuation phase) for lack of efficacy. | Posted | Mean | Standard Deviation | units on a scale | At end of week 5, except 1 d-amphetamine subject rated at end of week 2 |
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | 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. Frequency: once daily. Duration: 5 weeks | 0 | 12 | 4 | 12 |
| dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| decreased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| intermittent jitteriness | Nervous system disorders | Non-systematic Assessment |
|
| Decrease in drug dose | Blood and lymphatic system disorders | Non-systematic Assessment | non-sustained increase in pulse or systolic blood pressure |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment | irritability |
|
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| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |