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D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT00237809
First received: September 13, 2005
Last updated: March 30, 2017
Last verified: March 2017
  Purpose
This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA) receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.

Condition Intervention Phase
Schizophrenia Schizoaffective Disorder Drug: D-serine Behavioral: Cognitive Retraining (CRT) Drug: Placebo Behavioral: Cognitive Retraining Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Deepak C. D'Souza, Yale University:

Primary Outcome Measures:
  • Wisconsin Card Sorting Test (WCST) [ Time Frame: 12 weeks ]
    The WCST allows the clinician to speculate to the following "frontal" lobe functions: strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behavior toward achieving a goal, and modulating impulsive responding. The test can be administered to those from 6.5 years to 89 years of age.The test takes approximately 12-20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors. Can be interpreted as: the greater the percentage, the greater the measured ability.

  • Hopkins Verbal Learning Test [ Time Frame: 12 weeks ]
    The Hopkins Verbal Learning Test is designed to assess verbal learning and memory (immediate recall, delayed recall, delayed recognition). The assessment takes approximately 5-10 minutes with a 25-minute delay to complete and 2 minutes to score. The greater the score, the greater the measured recall. The score ranges from 0 to 24.

  • Spatial Span- Total Score [ Time Frame: 12 weeks ]
    The Spatial Span subtest of the Wechsler Memory Scale can be used as an indicator of working memory and visuospatial processing. An increase in severity of impairment results in a decrease in Spatial Span Total Score. The range is 1 to 28.

  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 12 weeks ]
    The PANSS is a handscored instrument. It uses 25 PANSS items organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The PANSS is based on findings that schizophrenia comprises at least two distinct syndromes. The positive syndrome consists of productive symptoms, while the negative syndrome consists of deficit features. This distinction is useful when developing treatment plans because you can focus on the type of symptoms the patient is experiencing. It is also useful when studying the effects of medication (e.g., in clinical drug trials) because it allows you to determine which type of symptoms are being affected. PANSS Total score minimum = 30, maximum = 210. The greater the score, the greater the symptoms.


Secondary Outcome Measures:
  • Heinrichs-Carpenter Quality of Life Scale [ Time Frame: 12 weeks ]
    The Heinrichs-Carpenter Quality of Life Scale is a testing device. It has a range of possible scores, 0-126 used to evaluate social functioning & behavior in patients with schizophrenia-lower scores represent poorer mental health.

  • Simpson-Angus Neurological Rating Scale [ Time Frame: 12 weeks ]
    Simpson-Angus Scale (SAS) is a 10-item rating scale that has been used widely for assessment in both clinical practice and research settings. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The highest possible score is 40.

  • UCSD Performance-Based Skills Assessment (UPSA) [ Time Frame: 12 weeks ]
    The UCSD Performance-Based Skills Assessment (UPSA) is a role-play test designed to evaluate a person's functional capacity in two selected areas of basic living skills. These areas include Finance and Communication. Subjects being tested utilize props to demonstrate how they perform everyday activities and are assessed on their actual performance. The higher the score, the better the performance of an individual. The scores range from 0 to 100.


Enrollment: 104
Study Start Date: September 2002
Study Completion Date: September 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug and control CRT
D-serine/control
Drug: D-serine
D-serine (30 mg/kg)
Behavioral: Cognitive Retraining Placebo
Cognitive retraining therapy (CRT) control
Experimental: Drug and CRT
D-serine/cog rehab
Drug: D-serine
D-serine (30 mg/kg)
Behavioral: Cognitive Retraining (CRT)
Cognitive retraining therapy (CRT)
Experimental: Placebo Drug and Placebo CRT
Placebo/control
Drug: Placebo
Placebo D-serine Drug
Behavioral: Cognitive Retraining Placebo
Cognitive retraining therapy (CRT) control
Experimental: Placebo Drug and CRT
Placebo/cog rehab
Behavioral: Cognitive Retraining (CRT)
Cognitive retraining therapy (CRT)
Drug: Placebo
Placebo D-serine Drug

Detailed Description:
Patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder

Exclusion

  • Pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237809

Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06508
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Alliance for Research on Schizophrenia and Depression
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Deepak C D'Souza, M.D. Yale University
  More Information

Publications:
Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00237809     History of Changes
Other Study ID Numbers: 23594
DF01-015
Study First Received: September 13, 2005
Results First Received: August 22, 2016
Last Updated: March 30, 2017

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Cognition Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders

ClinicalTrials.gov processed this record on June 28, 2017