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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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

Participant Flow for 2 periods

 Period 1:   First Study Week
    D-amphetamine   Caffeine Pills
STARTED   12   12 
COMPLETED   6 [1]   7 [2] 
NOT COMPLETED   6   5 
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 2:   4-week Study Continuation Phase
    D-amphetamine   Caffeine Pills
STARTED   6   7 
COMPLETED   5   7 
NOT COMPLETED   1   0 
Lack of Efficacy                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
24 Subjects meeting the listed entry criteria.

Reporting Groups
  Description
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.
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
Total Total of all reporting groups

Baseline Measures
   D-amphetamine   Caffeine Pills   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 12   12   24 
Age [1] 
[Units: Years]
Mean (Standard Deviation) 		     
Baseline Age   42.3  (12.8)   37.8  (13.7)   40.05  (13.25) 
[1] Mean Age, and standard deviation, in years
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      5  41.7%      6  50.0%      11  45.8% 
Male      7  58.3%      6  50.0%      13  54.2% 
Region of Enrollment 
[Units: Participants]
 		     
United States   12   12   24 
Prior Selective Serotonin Reuptake or Serotonin Norepinephrine Reuptake Inhibitor trials [1] [2] 
[Units: Trials]
Mean (Standard Deviation) 		 3.0 [1]   3.7 [2]   3.4 [2] 
[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 [1] 
[Units: Trials]
Mean (Standard Deviation) 		 2.4 [1]   2.5 [1]   2.5 [1] 
[1] Standard deviation was not calculated and the raw data is no longer available.


  Outcome Measures

1.  Primary:   Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2   [ Time Frame: At end of week 5, except 1 d-amphetamine subject rated at end of week 2 ]
  Show Outcome Measure 1

2.  Primary:   Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score   [ Time Frame: At end of week 5, except 1 d-amphetamine subject rated at end of week 2 ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Modest sample size of 24 subjects, 12 in each drug group. Observation period was only 5 weeks long.


  More Information

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:  
Name/Title: Lorrin M. Koran, M.D.
Organization: Stanford University Medical Center, Department of Psychiatry
phone: 650 498-5035
e-mail: lkoran@stanford.edu


Publications of Results:


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