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Trial record 43 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00455702
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: d-cycloserine
Enrollment 38
Recruitment Details Participants were stable adult outpatients at an urban community mental health center, ages 18-65 years, with a diagnosis of schizophrenia .
Pre-assignment Details  
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description 50 mg d-cycloserine 50 mg placebo
Period Title: Overall Study
Started 19 19
Completed 16 16
Not Completed 3 3
Arm/Group Title D-cycloserine Placebo Total
Hide Arm/Group Description 50 mg d-cycloserine 50 mg placebo Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
19
 100.0%
38
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
50.1  (9.15) 48  (6.66) 49.05  (7.905)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
9
  47.4%
6
  31.6%
15
  39.5%
Male
10
  52.6%
13
  68.4%
23
  60.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
1.Primary Outcome
Title Main Outcome Measure: The Change From Baseline to Week 8 on the SANS
Hide Description The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).
Time Frame Baseline score vs. Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
50 mg d-cycloserine
50 mg placebo
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.06  (5.03) -2.11  (7.05)
2.Secondary Outcome
Title Treatment Effects on the Positive Syndrome Subscale of the PANSS
Hide Description The change from baseline to week 8 on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).
Time Frame Baseline score vs. Week 8 score
Hide Outcome Measure Data
Hide Analysis Population Description
One participant from the placebo group was removed from this analysis.
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:

50 mg d-cycloserine

d-cycloserine: 50mg dose d-cycloserine v placebo

50 mg placebo

d-cycloserine: 50mg dose d-cycloserine v placebo

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: PANSS Positive Subscale Units
.19  (2.10) -.19  (4.65)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description 50 mg d-cycloserine 50 mg placebo
All-Cause Mortality
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      0/19 (0.00%)    
Psychiatric disorders     
Worsening psychosis due to discontinuation of anti-psychotic  1/19 (5.26%)  1 0/19 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-cycloserine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/19 (42.11%)      13/19 (68.42%)    
Cardiac disorders     
Chest pain  0/19 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders     
Diarrhea  0/19 (0.00%)  0 2/19 (10.53%)  2
Vomiting  1/19 (5.26%)  1 0/19 (0.00%)  0
Heartburn  0/19 (0.00%)  0 2/19 (10.53%)  2
General disorders     
Fatigue  1/19 (5.26%)  1 0/19 (0.00%)  0
Fracture (foot)  0/19 (0.00%)  0 1/19 (5.26%)  1
Headache  2/19 (10.53%)  2 0/19 (0.00%)  0
Nausea  0/19 (0.00%)  0 1/19 (5.26%)  1
Vertigo  0/19 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations     
Bronchitis  1/19 (5.26%)  1 0/19 (0.00%)  0
Psychiatric disorders     
Depression  1/19 (5.26%)  1 2/19 (10.53%)  2
Respiratory, thoracic and mediastinal disorders     
URI  2/19 (10.53%)  2 2/19 (10.53%)  2
Social circumstances     
Anxiety  0/19 (0.00%)  0 1/19 (5.26%)  1
As the first study of once-weekly dosing in Schizophrenia, this study was exploratory and so results must be considered preliminary. Additional studies are needed to replicate these findings.
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: Donald C Goff
Organization: Massachusetts General Hopsital
Phone: 617-912-7899
Responsible Party: Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00455702     History of Changes
Other Study ID Numbers: 2005-P-001040
First Submitted: April 2, 2007
First Posted: April 4, 2007
Results First Submitted: June 11, 2014
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014