Trial Outcomes & Findings for Using D-cycloserine to Enhance the Benefits of Cognitive Behavioral Therapy for Schizophrenia (NCT NCT00742079)
NCT ID: NCT00742079
Last Updated: 2017-12-19
Results Overview
Number of alternative beliefs generated on the Alternative Beliefs Assessment. This assessment used nine vignettes describing social interactions: three of neutral content, three negatively-valanced, and three tailored to the patient's specific delusions. Participants were asked to generate as many explanations (alternative beliefs) as they could for each scenario, and the number of explanations produced in response to each item was recorded. Scores could range from 0 to as many explanations a person could produce (no maximum value). The total score was calculated by adding all alternative beliefs generated from each vignette. A higher number of alternative beliefs generated reflects a greater degree of cognitive flexibility.
COMPLETED
PHASE4
21 participants
Baseline to Week 2
2017-12-19
Participant Flow
Participants were recruited from an urban community mental health center in Boston, MA from September 2006 to May 2010.
31 participants were screened, 10 were excluded (7 did not meet inclusion criteria and 2 refused to participate, 1 excluded for reasons not listed in study publication)
Participant milestones
| Measure |
1 D-cycloserine First, Then Placebo
Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
|
2 Placebo First, Then D-cycloserine
Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
Baseline/Week 1 (Received Dose 1)
|
11
|
9
|
|
Overall Study
Week 2 (Received Dose 2)
|
11
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
1 D-cycloserine First, Then Placebo
Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
|
2 Placebo First, Then D-cycloserine
Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Using D-cycloserine to Enhance the Benefits of Cognitive Behavioral Therapy for Schizophrenia
Baseline characteristics by cohort
| Measure |
1 D-cycloserine, Then Placebo
n=11 Participants
Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
|
2 Placebo, Then D-cycloserine
n=9 Participants
Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 2Number of alternative beliefs generated on the Alternative Beliefs Assessment. This assessment used nine vignettes describing social interactions: three of neutral content, three negatively-valanced, and three tailored to the patient's specific delusions. Participants were asked to generate as many explanations (alternative beliefs) as they could for each scenario, and the number of explanations produced in response to each item was recorded. Scores could range from 0 to as many explanations a person could produce (no maximum value). The total score was calculated by adding all alternative beliefs generated from each vignette. A higher number of alternative beliefs generated reflects a greater degree of cognitive flexibility.
Outcome measures
| Measure |
D-cycloserine
n=20 Participants
Participants receive 50 mg of D-cycloserine
|
Placebo
n=20 Participants
Participants receive 50 mg of placebo
|
|---|---|---|
|
Change in Alternative Beliefs Assessment
|
14.05 units on a scale
Standard Deviation 12.71
|
10.70 units on a scale
Standard Deviation 16.08
|
SECONDARY outcome
Timeframe: Baseline to Week 2The Delusions subscale is a 6 item clinician administered scale, with Likert items 0-4 and range is 0-24. Higher scores represent worse outcomes
Outcome measures
| Measure |
D-cycloserine
n=19 Participants
Participants receive 50 mg of D-cycloserine
|
Placebo
n=19 Participants
Participants receive 50 mg of placebo
|
|---|---|---|
|
Change in Psychotic Rating Scales (PSYRATS) Delusion Score
|
-0.89 units on a scale
Standard Deviation 2.49
|
-0.47 units on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: Baseline to Week 2The BCIS is a 15-item self-report scale with Likert items 0-3. It consists of a composite score, where higher scores represent better outcomes, and there are 2 subscales: 1) Self-Reflectiveness (higher scores represent better outcomes) and 2) Self-Certainty (higher scores represent worse outcomes). The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty. Step 1. Score every item on the BCIS from "0" to "3" according to the following rule: "Do Not Agree at All" = 0, "Agree Slightly" = 1, "Agree a Lot" = 2, "Agree Completely" = 3 Step 2. Calculate self-reflectiveness subscale: sum items 1, 3, 4, 5, 6, 8, 12, 14, and 15. Step 3. Calculate self-certainty subscale: sum items 2, 7, 9, 10, 11, and 13. Step 4. Calculate BCIS composite index: self-reflectiveness minus self-certainty.
Outcome measures
| Measure |
D-cycloserine
n=19 Participants
Participants receive 50 mg of D-cycloserine
|
Placebo
n=18 Participants
Participants receive 50 mg of placebo
|
|---|---|---|
|
Change in Beck Cognitive Insight Scale (BCIS)
Composite Score
|
-0.26 units on a scale
Standard Deviation 3.46
|
0.44 units on a scale
Standard Deviation 4.16
|
|
Change in Beck Cognitive Insight Scale (BCIS)
Self-Certainty Score
|
0.11 units on a scale
Standard Deviation 3.68
|
-0.56 units on a scale
Standard Deviation 2.64
|
|
Change in Beck Cognitive Insight Scale (BCIS)
Self-Reflectiveness Score
|
-0.16 units on a scale
Standard Deviation 2.81
|
-0.11 units on a scale
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: Baseline to Week 2The Bead task is a reasoning task, where the number of beads guessed is the numeric value represented in the data. The lower end range is 1, and there is no upper range limit. Higher scores represent better outcomes.
Outcome measures
| Measure |
D-cycloserine
n=20 Participants
Participants receive 50 mg of D-cycloserine
|
Placebo
n=20 Participants
Participants receive 50 mg of placebo
|
|---|---|---|
|
Change in Bead Task Score Measuring Probabilistic Reasoning
|
0.45 units on a scale
Standard Deviation 4.47
|
0.10 units on a scale
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: Baseline to Week 2This scale is a one-question item added on to the Bead Task. The one item asks for a certainty rating, from 1-3. Higher scores represent better outcomes.
Outcome measures
| Measure |
D-cycloserine
n=19 Participants
Participants receive 50 mg of D-cycloserine
|
Placebo
n=19 Participants
Participants receive 50 mg of placebo
|
|---|---|---|
|
Change in the Maudsley Assessment of Delusions Scale
|
0.05 units on a scale
Standard Deviation 0.40
|
-0.16 units on a scale
Standard Deviation 0.37
|
Adverse Events
1 D-cycloserine, Then Placebo
2 Placebo, Then D-cycloserine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place