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Trial record 71 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Trial of D-Cycloserine in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000371
Recruitment Status : Completed
First Posted : November 3, 1999
Results First Posted : September 10, 2014
Last Update Posted : September 10, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: D-cycloserine
Drug: Placebo
Enrollment 60
Recruitment Details Subjects were adult outpatients recruited from three urban community health centers and two Veteran's Affairs medical centers in the greater Boston area. All eligible participants at these sites were invited to participate by their clinicians.
Pre-assignment Details Sixty subjects met eligibility criteria and provided informed consent, but just 55 completed baseline assessments and were randomized to d-cycloserine or placebo.
Arm/Group Title D-Cycloserine Placebo
Hide Arm/Group Description Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics. Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
Period Title: Overall Study
Started 27 28
Completed 14 12
Not Completed 13 16
Arm/Group Title D-Cycloserine Placebo Total
Hide Arm/Group Description Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics. Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics. Total of all reporting groups
Overall Number of Baseline Participants 27 28 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 28 participants 55 participants
45.9  (7.4) 47.0  (8.6) 46.5  (8.0)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
28
 100.0%
55
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 28 participants 55 participants
Female
3
  11.1%
8
  28.6%
11
  20.0%
Male
24
  88.9%
20
  71.4%
44
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 28 participants 55 participants
27 28 55
1.Primary Outcome
Title Scale for the Assessment of Negative Symptoms (SANS)
Hide Description The slope of SANS total score from baseline to week 8 in the treatment and placebo groups 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 slopes were obtained by plotting the group SANS total score mean for treatment vs. placebo on Baseline, Week 4, and Week 8 and performing a random slopes model.
Time Frame Baseline, Week 4, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-Cycloserine Placebo
Hide Arm/Group Description:
Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
Overall Number of Participants Analyzed 28 27
Mean (Standard Error)
Unit of Measure: units on a scale/weeks
-.46  (.29) -.41  (.31)
Time Frame [Not Specified]
Adverse Event Reporting Description The only information known for this study regarding occurrence of Adverse Events is that 2 and 6 participants dropped out of the D-Cycloserine and Placebo Arms/Groups, respectively (reported in the publication associated with this clinical trials profile). However, specific adverse event data are lost and cannot be retrieved
 
Arm/Group Title D-Cycloserine Placebo
Hide Arm/Group Description Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics. Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
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 (%) Affected / at Risk (%)
Total   0/0   0/0 
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 (%) Affected / at Risk (%)
Total   0/0   0/0 
A biased sample may have been produced by restricting the analysis to patients with prominent negative symptoms receiving conventional agents (less compliant with study medication). Additionally, Adverse Event data was lost for the study.
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: Dr. Donald Goff
Organization: Freedom Clinic Trail, Massachusetts General Hospital
Phone: 617-921-7899
Responsible Party: Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00000371     History of Changes
Other Study ID Numbers: R01MH054245-01A2 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 1999
First Posted: November 3, 1999
Results First Submitted: August 11, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014