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Trial record 1 of 74 for:    AMPHETAMINE AND DEXTROAMPHETAMINE
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Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

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ClinicalTrials.gov Identifier: NCT00363298
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
Obsessive Compulsive Foundation
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obsessive-Compulsive Disorder
Interventions Drug: dextro-amphetamine
Drug: Sham Comparison
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D-amphetamine Caffeine Pills
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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.

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
Period Title: First Study Week
Started 12 12
Completed 6 [1] 7 [2]
Not Completed 6 5
Reason Not Completed
Lack of Efficacy             6             5
[1]
At end of week 1, 6/12 subjects met Y-BOCS response criterion and began 4-week continuation phase
[2]
At end of week 1, 7/12 subjects met Y-BOCS response criterion and began 4-week continuation phase
Period Title: 4-week Study Continuation Phase
Started 6 7
Completed 5 7
Not Completed 1 0
Reason Not Completed
Lack of Efficacy             1             0
Arm/Group Title D-amphetamine Caffeine Pills Total
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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.

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 Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
24 Subjects meeting the listed entry criteria.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Baseline Age Number Analyzed 12 participants 12 participants 24 participants
42.3  (12.8) 37.8  (13.7) 40.05  (13.25)
[1]
Measure Description: Mean Age, and standard deviation, in years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
5
  41.7%
6
  50.0%
11
  45.8%
Male
7
  58.3%
6
  50.0%
13
  54.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
Prior Selective Serotonin Reuptake or Serotonin Norepinephrine Reuptake Inhibitor trials  
Mean (Standard Deviation)
Unit of measure:  Trials
Number Analyzed 12 participants 12 participants 24 participants
3.0 [1]   (NA) 3.7 [2]   (NA) 3.4 [2]   (NA)
[1]
Standard deviation was not calculated and the raw data are no longer available
[2]
Standard deviation was not calculated and the raw data are no longer available.
Atypical antipsychotic drug augmentation trials  
Mean (Standard Deviation)
Unit of measure:  Trials
Number Analyzed 12 participants 12 participants 24 participants
2.4 [1]   (NA) 2.5 [1]   (NA) 2.5 [1]   (NA)
[1]
Standard deviation was not calculated and the raw data is no longer available.
1.Primary Outcome
Title Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2
Hide 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
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Hide Analysis Population Description
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
Arm/Group Title D-amphetamine Caffeine Pills
Hide Arm/Group 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.

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.

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
Overall Number of Participants Analyzed 6 7
Measure Type: Number
Unit of Measure: participants
6 7
2.Primary Outcome
Title Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title D-amphetamine Caffeine Pills
Hide Arm/Group Description:

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.

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
Overall Number of Participants Analyzed 6 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.3  (6.9) 13.0  (8.4)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-amphetamine Caffeine Pills
Hide Arm/Group 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. 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
All-Cause Mortality
D-amphetamine Caffeine Pills
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
D-amphetamine Caffeine Pills
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-amphetamine Caffeine Pills
Affected / at Risk (%) Affected / at Risk (%)
Total   5/12 (41.67%)   4/12 (33.33%) 
Blood and lymphatic system disorders     
Decrease in drug dose * [1]  3/12 (25.00%)  1/12 (8.33%) 
Gastrointestinal disorders     
dry mouth *  2/12 (16.67%)  0/12 (0.00%) 
decreased appetite *  1/12 (8.33%)  0/12 (0.00%) 
nausea *  0/12 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
intermittent jitteriness *  0/12 (0.00%)  1/12 (8.33%) 
Psychiatric disorders     
insomnia *  2/12 (16.67%)  2/12 (16.67%) 
Irritability * [2]  0/12 (0.00%)  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
[1]
non-sustained increase in pulse or systolic blood pressure
[2]
irritability
Modest sample size of 24 subjects, 12 in each drug group. Observation period was only 5 weeks long.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lorrin M. Koran, M.D.
Organization: Stanford University Medical Center, Department of Psychiatry
Phone: 650 498-5035
EMail: lkoran@stanford.edu
Layout table for additonal information
Responsible Party: Lorrin M Koran, Stanford University
ClinicalTrials.gov Identifier: NCT00363298     History of Changes
Other Study ID Numbers: 97134
First Submitted: August 9, 2006
First Posted: August 15, 2006
Results First Submitted: April 20, 2015
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017