Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD

• 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: Stanford University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	D-amphetamine	Caffeine Pills
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
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

Baseline Characteristics

Arm/Group Title		D-amphetamine	Caffeine Pills	Total
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	Total of all reporting groups
Overall Number of Baseline Participants		12	12	24
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.

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--	--/--
Serious Adverse Events
	D-amphetamine	Caffeine Pills
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/12 (0.00%)	0/12 (0.00%)
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

Limitations and Caveats

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
• EMail: lkoran@stanford.edu

Publications of Results:

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.

• Responsible Party: Lorrin M Koran, Stanford University
• ClinicalTrials.gov Identifier: NCT00363298
• 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