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Biomarkers in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00817336
Recruitment Status : Completed
First Posted : January 6, 2009
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: D Serine
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
D-serine Followed by Placebo subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.
Placebo Followed by D-serine subjects received a fixed dose of D-serine 60 mg/kg/day in a randomized, placebo-controlled crossover study of d-serine and placebo each for 6 weeks. Subjects were randomly assigned to receive (d-serine or placebo) in the first treatment phase, followed by two-weeks of single-blind placebo, which was followed by the alternative treatment in a second-phase.

Participant Flow:   Overall Study
    D-serine Followed by Placebo   Placebo Followed by D-serine
STARTED   8   8 
COMPLETED   7   7 
NOT COMPLETED   1   1 
Withdrawal by Subject                1                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.
There were no statistically significant differences by treatment order

Reporting Groups
  Description
D-serine Followed by Placebo Does not include 1 drop-out during phase 1
Placebo Followed by D-serine Does not include 1 drop-out during phase 1
Total Total of all reporting groups

Baseline Measures
   D-serine Followed by Placebo   Placebo Followed by D-serine   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
Age 
[Units: Years]
Mean (Standard Deviation)
 36  (10)   44.6  (11)   40  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  14.3%      0   0.0%      1   7.1% 
Male      6  85.7%      7 100.0%      13  92.9% 
In-patient number 
[Units: Participants]
Count of Participants
 6   4   10 
Chlorpromazine equivalents 
[Units: Mg]
Mean (Standard Deviation)
 1135  (967)   795  (496)   965  (760) 
PANSS total [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 83.7  (9)   80.1  (10)   80.8  (8.4) 
[1] Positive and Negative Symptom Scale (PANSS) range from 30-210, with higher scores worse


  Outcome Measures

1.  Primary:   PANSS Total   [ Time Frame: 6 weeks ]

2.  Primary:   MMN Amplitude   [ Time Frame: 6 weeks ]

3.  Secondary:   MATRICS   [ Time Frame: 6 weeks ]

4.  Secondary:   Visual P1   [ Time Frame: 6 weeks ]


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joshua Kantrowitz
Organization: Nathan Kline Institute
phone: 646-774-6738
e-mail: jk3380@cumc.columbia.edu



Responsible Party: Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT00817336     History of Changes
Other Study ID Numbers: 08I/C19-0
First Submitted: January 5, 2009
First Posted: January 6, 2009
Results First Submitted: December 15, 2016
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017