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D-serine for the Schizophrenia Prodrome

This study has been completed.
Sponsor:
Collaborators:
Yale University
The Zucker Hillside Hospital
National Institute of Mental Health (NIMH)
Information provided by:
Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00826202
First received: January 21, 2009
Last updated: December 15, 2016
Last verified: December 2016
Results First Received: April 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia Prodrome
Interventions: Drug: D-serine
Other: Placebo

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
D Serine

60 mg/kg/day

D-serine: 60 mg/kg/day

Placebo Placebo: Inert Placebo

Participant Flow:   Overall Study
    D Serine   Placebo
STARTED   20   24 
Completed Visit 4 (1st Efficacy Visit)   15   20 
COMPLETED   10   11 
NOT COMPLETED   10   13 



  Baseline Characteristics
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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.
Includes 35 subjects who received at least one post-baseline efficacy evaluation

Reporting Groups
  Description
D Serine

60 mg/kg/day

D-serine: 60 mg/kg/day

Placebo Placebo: Inert Placebo
Total Total of all reporting groups

Baseline Measures
   D Serine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   20   35 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      7  46.7%      9  45.0%      16  45.7% 
Between 18 and 65 years      8  53.3%      11  55.0%      19  54.3% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 20  (4.9)   19  (3.5)   19.5  (4.1) 
Gender 
[Units: Participants]
Count of Participants
     
Female      7  46.7%      5  25.0%      12  34.3% 
Male      8  53.3%      15  75.0%      23  65.7% 
Region of Enrollment 
[Units: Participants]
     
United States   15   20   35 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   SOPS Negative Scale   [ Time Frame: 16 weeks ]

2.  Secondary:   Scale of Prodromal Symptoms (SOPS) Total   [ Time Frame: 16 weeks ]

3.  Secondary:   IL6 Levels   [ Time Frame: 16 weeks ]

4.  Secondary:   Pittsburgh Sleep Quality Index Score   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Daniel Javitt MD, PhD
Organization: Nathan Kline Institute
phone: 845-398-6534
e-mail: javitt@nki.rfmh.org



Responsible Party: Daniel Javitt MD, Nathan Kline Institute
ClinicalTrials.gov Identifier: NCT00826202     History of Changes
Other Study ID Numbers: 08I/C33
CDDG 1 U01 MH074356-01
Study First Received: January 21, 2009
Results First Received: April 15, 2015
Last Updated: December 15, 2016