D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia
|ClinicalTrials.gov Identifier: NCT00237809|
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : May 10, 2017
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Drug: D-serine Behavioral: Cognitive Retraining (CRT) Drug: Placebo Behavioral: Cognitive Retraining Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia|
|Study Start Date :||September 2002|
|Primary Completion Date :||December 2010|
|Study Completion Date :||September 2012|
Experimental: Drug and control CRT
D-serine (30 mg/kg)Behavioral: Cognitive Retraining Placebo
Cognitive retraining therapy (CRT) control
Experimental: Drug and CRT
D-serine (30 mg/kg)Behavioral: Cognitive Retraining (CRT)
Cognitive retraining therapy (CRT)
Experimental: Placebo Drug and Placebo CRT
Placebo D-serine DrugBehavioral: Cognitive Retraining Placebo
Cognitive retraining therapy (CRT) control
Experimental: Placebo Drug and CRT
Behavioral: Cognitive Retraining (CRT)
Cognitive retraining therapy (CRT)Drug: Placebo
Placebo D-serine Drug
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237809
|United States, Connecticut|
|Connecticut Mental Health Center|
|New Haven, Connecticut, United States, 06508|
|VA Connecticut Healthcare System|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Deepak C D'Souza, M.D.||Yale University|