Trial Outcomes & Findings for Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD (NCT NCT00363298)
NCT ID: NCT00363298
Last Updated: 2017-03-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
At end of week 5, except 1 d-amphetamine subject rated at end of week 2
Results posted on
2017-03-28
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
First Study Week
STARTED
|
12
|
12
|
|
First Study Week
COMPLETED
|
6
|
7
|
|
First Study Week
NOT COMPLETED
|
6
|
5
|
|
4-week Study Continuation Phase
STARTED
|
6
|
7
|
|
4-week Study Continuation Phase
COMPLETED
|
5
|
7
|
|
4-week Study Continuation Phase
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
First Study Week
Lack of Efficacy
|
6
|
5
|
|
4-week Study Continuation Phase
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD
Baseline characteristics by cohort
| Measure |
D-amphetamine
n=12 Participants
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
n=12 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Baseline Age
|
42.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
40.05 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Prior Selective Serotonin Reuptake or Serotonin Norepinephrine Reuptake Inhibitor trials
|
3.0 trials
STANDARD_DEVIATION NA • n=5 Participants
|
3.7 trials
STANDARD_DEVIATION NA • n=7 Participants
|
3.4 trials
STANDARD_DEVIATION NA • n=5 Participants
|
|
Atypical antipsychotic drug augmentation trials
|
2.4 trials
STANDARD_DEVIATION NA • n=5 Participants
|
2.5 trials
STANDARD_DEVIATION NA • n=7 Participants
|
2.5 trials
STANDARD_DEVIATION NA • n=5 Participants
|
PRIMARY outcome
Timeframe: At end of week 5, except 1 d-amphetamine subject rated at end of week 2Population: 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
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).
Outcome measures
| Measure |
D-amphetamine
n=6 Participants
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
n=7 Participants
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
|
|---|---|---|
|
Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2
|
6 participants
|
7 participants
|
PRIMARY outcome
Timeframe: At end of week 5, except 1 d-amphetamine subject rated at end of week 2Population: 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.
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.
Outcome measures
| Measure |
D-amphetamine
n=6 Participants
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
n=7 Participants
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
|
|---|---|---|
|
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score
|
13.3 units on a scale
Standard Deviation 6.9
|
13.0 units on a scale
Standard Deviation 8.4
|
Adverse Events
D-amphetamine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Caffeine Pills
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D-amphetamine
n=12 participants at risk
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 Pills
n=12 participants at risk
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
|
|---|---|---|
|
Psychiatric disorders
insomnia
|
16.7%
2/12 • 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.
|
16.7%
2/12 • 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.
|
|
Gastrointestinal disorders
dry mouth
|
16.7%
2/12 • 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.
|
0.00%
0/12 • 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.
|
|
Gastrointestinal disorders
decreased appetite
|
8.3%
1/12 • 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.
|
0.00%
0/12 • 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.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/12 • 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.
|
8.3%
1/12 • 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.
|
|
Nervous system disorders
intermittent jitteriness
|
0.00%
0/12 • 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.
|
8.3%
1/12 • 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.
|
|
Blood and lymphatic system disorders
Decrease in drug dose
|
25.0%
3/12 • 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.
|
8.3%
1/12 • 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.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/12 • 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.
|
8.3%
1/12 • 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.
|
Additional Information
Lorrin M. Koran, M.D.
Stanford University Medical Center, Department of Psychiatry
Phone: 650 498-5035
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place