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D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00963924
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : August 20, 2014
Last Update Posted : February 6, 2018
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: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: D-cycloserine
Drug: Placebo
Behavioral: Cognitive Remediation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
54 patients were assessed for eligibility; however, 14 were excluded (11 were ineligible, and 3 withdrew consent). 40 participants were randomized, however 4 were excluded (1 serious adverse event, 2 withdrew consent, and 1 was lost to follow up), therefore 36 entered the treatment phase.

Reporting Groups
  Description
D-cycloserine Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.

Participant Flow:   Overall Study
    D-cycloserine   Placebo
STARTED   18   18 
COMPLETED   17   15 
NOT COMPLETED   1   3 
Adverse Event                1                0 
Withdrawal by Subject                0                1 
Changed antipsychotic                0                1 
Lost to Follow-up                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
D-cycloserine Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Total Total of all reporting groups

Baseline Measures
   D-cycloserine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      18 100.0%      18 100.0%      36 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.8  (11.5)   46.2  (13.3)   47.5  (12.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  11.1%      3  16.7%      5  13.9% 
Male      16  88.9%      15  83.3%      31  86.1% 
Region of Enrollment 
[Units: Participants]
     
United States   18   18   36 


  Outcome Measures

1.  Primary:   Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)   [ Time Frame: Baseline vs. Week 8 ]

2.  Primary:   Scale for Assessment of Negative Symptoms (SANS)   [ Time Frame: Baseline vs. Week 8 ]

3.  Primary:   Auditory Discrimination Task: Interstimulus Interval (ISI)   [ Time Frame: Baseline vs. Week 8 ]

4.  Secondary:   Positive and Negative Syndrome Scale (PANSS)   [ Time Frame: Baseline ]

5.  Secondary:   Global Assessment of Functioning Scale (GAS)   [ Time Frame: Baseline ]

6.  Secondary:   Heinrich Quality of Life Scale (QoL)   [ Time Frame: Baseline ]

7.  Secondary:   Calgary Depression Scale for Schizophrenia (CDSS)   [ Time Frame: Baseline ]

8.  Secondary:   Clinical Global Impression (CGI)   [ Time Frame: Weeks 0 and 8, and Month 6 after cognitive remediation completion ]

9.  Secondary:   Side Effects Checklist (SEC)   [ Time Frame: Weeks 0 - 8, and Month 6 after cognitive remediation completion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 C Goff
Organization: Nathan Klein Institute for Psychiatric Research
phone: 646-754-4843
e-mail: donald.goff@nyumc.org


Publications of Results:

Responsible Party: Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00963924     History of Changes
Other Study ID Numbers: 2008P002237
5P50MH060450 ( U.S. NIH Grant/Contract )
DATR A3-NSC
First Submitted: August 20, 2009
First Posted: August 24, 2009
Results First Submitted: June 23, 2014
Results First Posted: August 20, 2014
Last Update Posted: February 6, 2018