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Trial record 37 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Using D-cycloserine to Enhance the Benefits of Cognitive Behavioral Therapy for Schizophrenia

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ClinicalTrials.gov Identifier: NCT00742079
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : September 5, 2014
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: D-cycloserine
Behavioral: Cognitive Behavioral Therapy
Enrollment 21
Recruitment Details Participants were recruited from an urban community mental health center in Boston, MA from September 2006 to May 2010.
Pre-assignment Details 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)
Arm/Group Title 1 D-cycloserine First, Then Placebo 2 Placebo First, Then D-cycloserine
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 11 10
Baseline/Week 1 (Received Dose 1) 11 9
Week 2 (Received Dose 2) 11 9
Completed 11 9
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title 1 D-cycloserine, Then Placebo 2 Placebo, Then D-cycloserine Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 20 participants
49.2  (9.0) 51.4  (13.0) 50.2  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
5
  45.5%
2
  22.2%
7
  35.0%
Male
6
  54.5%
7
  77.8%
13
  65.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  18.2%
1
  11.1%
3
  15.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  18.2%
2
  22.2%
4
  20.0%
White
7
  63.6%
6
  66.7%
13
  65.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 9 participants 20 participants
11 9 20
1.Primary Outcome
Title Change in Alternative Beliefs Assessment
Hide Description 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.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants receive 50 mg of D-cycloserine
Participants receive 50 mg of placebo
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.05  (12.71) 10.70  (16.08)
2.Secondary Outcome
Title Change in Psychotic Rating Scales (PSYRATS) Delusion Score
Hide Description The Delusions subscale is a 6 item clinician administered scale, with Likert items 0-4 and range is 0-24. Higher scores represent worse outcomes
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants receive 50 mg of D-cycloserine
Participants receive 50 mg of placebo
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.89  (2.49) -0.47  (3.08)
3.Secondary Outcome
Title Change in Beck Cognitive Insight Scale (BCIS)
Hide Description

The 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.

Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants receive 50 mg of D-cycloserine
Participants receive 50 mg of placebo
Overall Number of Participants Analyzed 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Composite Score -0.26  (3.46) 0.44  (4.16)
Self-Certainty Score 0.11  (3.68) -0.56  (2.64)
Self-Reflectiveness Score -0.16  (2.81) -0.11  (3.23)
4.Secondary Outcome
Title Change in Bead Task Score Measuring Probabilistic Reasoning
Hide Description The 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.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants receive 50 mg of D-cycloserine
Participants receive 50 mg of placebo
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.45  (4.47) 0.10  (5.16)
5.Secondary Outcome
Title Change in the Maudsley Assessment of Delusions Scale
Hide Description This 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.
Time Frame Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
Participants receive 50 mg of D-cycloserine
Participants receive 50 mg of placebo
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.05  (0.40) -0.16  (0.37)
Time Frame Three week period from baseline until week 2 of treatment.
Adverse Event Reporting Description No adverse events were reported following ingestion of study drug.
 
Arm/Group Title 1 D-cycloserine, Then Placebo 2 Placebo, Then D-cycloserine
Hide Arm/Group Description 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. 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.
All-Cause Mortality
1 D-cycloserine, Then Placebo 2 Placebo, Then D-cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1 D-cycloserine, Then Placebo 2 Placebo, Then D-cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 D-cycloserine, Then Placebo 2 Placebo, Then D-cycloserine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
The cross-over design of this study produced results that are difficult to interpret due to a significant order effect. Larger and longer trials are needed to assess whether this treatment may benefit patients with medication resistant delusions.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jennifer Gottlieb, PhD
Organization: Massachusetts General Hospital
Phone: 617-912-7800
Responsible Party: Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00742079     History of Changes
Other Study ID Numbers: P50MH060450 ( U.S. NIH Grant/Contract )
2P50MH060450-07A1 ( U.S. NIH Grant/Contract )
DATR A3-NSC ( Other Grant/Funding Number: National Institute of Mental Health )
First Submitted: August 25, 2008
First Posted: August 27, 2008
Results First Submitted: August 11, 2014
Results First Posted: September 5, 2014
Last Update Posted: December 19, 2017