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| ID | Type | Description | Link |
|---|---|---|---|
| DF01-015 |
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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
| Donaghue Medical Research Foundation | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug and control CRT | Experimental | D-serine/control |
|
| Drug and CRT | Experimental | D-serine/cog rehab |
|
| Placebo Drug and Placebo CRT | Experimental | Placebo/control |
|
| Placebo Drug and CRT | Experimental | Placebo/cog rehab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-serine | Drug | D-serine (30 mg/kg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wisconsin Card Sorting Test (WCST) | 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. | 12 weeks |
| Hopkins Verbal Learning Test | 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. | 12 weeks |
| Spatial Span- Total Score | 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. | 12 weeks |
| Positive and Negative Syndrome Scale (PANSS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heinrichs-Carpenter Quality of Life Scale | 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. | 12 weeks |
| Simpson-Angus Neurological Rating Scale |
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Inclusion Criteria:
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Deepak C D'Souza, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06508 | United States | ||
| VA Connecticut Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10553752 | Background | Tsai GE, Yang P, Chung LC, Tsai IC, Tsai CW, Coyle JT. D-serine added to clozapine for the treatment of schizophrenia. Am J Psychiatry. 1999 Nov;156(11):1822-5. doi: 10.1176/ajp.156.11.1822. | |
| 9836012 | Background | Tsai G, Yang P, Chung LC, Lange N, Coyle JT. D-serine added to antipsychotics for the treatment of schizophrenia. Biol Psychiatry. 1998 Dec 1;44(11):1081-9. doi: 10.1016/s0006-3223(98)00279-0. |
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132 subjects were screened for eligibility. After screening, eligible subjects were randomized to receive: D-serine+CRT, placebo D-serine+CRT, D-serine + control CRT, or placebo D-serine + control CRT. Randomization was stratified by screening performance IQ. Separate randomization schedules (block size= 4) were generated within IQ stratum.
Subjects were enrolled between 2003 and 2008, with enrollment of subjects in India starting later (2005) and ending in 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | D-serine Drug /CRT Placebo | D-serine/control D-serine : D-serine (30 mg/kg) |
| FG001 | Placebo Drug /CRT | Placebo/cog rehab Cognitive retraining : Cog rehab |
| FG002 | D-serine Drug/CRT | D-serine/cog rehab D-serine : D-serine (30 mg/kg) |
| FG003 | Placebo Drug/ Placebo CRT | Placebo/control |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | D-serine/Control | D-serine/control D-serine : D-serine (30 mg/kg) |
| BG001 | Placebo/Cog Rehab | Placebo/cog rehab Cognitive retraining : Cog rehab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wisconsin Card Sorting Test (WCST) | 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. | Posted | Mean | Standard Deviation | percentage of correct responses | 12 weeks |
|
Adverse events (serious and other) are reported overall at the month time frame.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-serine/Control | D-serine/control D-serine : D-serine (30 mg/kg) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concentration Difficulty | Psychiatric disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deepak Cyril D'Souza | Yale University | 203-932-5711 | 2594 | deepak.dsouza@yale.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Cognitive Retraining (CRT) |
| Behavioral |
Cognitive retraining therapy (CRT) |
|
| Placebo | Drug | Placebo D-serine Drug |
|
| Cognitive Retraining Placebo | Behavioral | Cognitive retraining therapy (CRT) control |
|
| 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. |
| 12 weeks |
| UCSD Performance-Based Skills Assessment (UPSA) | 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. | 12 weeks |
| West Haven |
| Connecticut |
| 06516 |
| United States |
| 15780844 | Background | Heresco-Levy U, Javitt DC, Ebstein R, Vass A, Lichtenberg P, Bar G, Catinari S, Ermilov M. D-serine efficacy as add-on pharmacotherapy to risperidone and olanzapine for treatment-refractory schizophrenia. Biol Psychiatry. 2005 Mar 15;57(6):577-85. doi: 10.1016/j.biopsych.2004.12.037. |
| BG002 | D-serine/Cog Rehab | D-serine/cog rehab D-serine : D-serine (30 mg/kg) |
| BG003 | Placebo/Control | Placebo/control Cognitive retraining : Cog rehab |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo/Cog Rehab |
Placebo/cog rehab Cognitive retraining : Cog rehab |
| OG002 | D-serine/Cog Rehab | D-serine/cog rehab D-serine : D-serine (30 mg/kg) |
| OG003 | Placebo/Control | Placebo/control Cognitive retraining : video |
|
|
| Primary | Hopkins Verbal Learning Test | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Primary | Spatial Span- Total Score | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Primary | Positive and Negative Syndrome Scale (PANSS) | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Heinrichs-Carpenter Quality of Life Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Simpson-Angus Neurological Rating Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | UCSD Performance-Based Skills Assessment (UPSA) | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| 0 |
| 27 |
| 14 |
| 27 |
| EG001 | Placebo/Cog Rehab | Placebo/cog rehab Cognitive retraining : Cog rehab | 0 | 27 | 14 | 27 |
| EG002 | D-serine/Cog Rehab | D-serine/cog rehab D-serine : D-serine (30 mg/kg) | 0 | 24 | 12 | 24 |
| EG003 | Placebo/Control | Placebo/control Cognitive retraining : video | 0 | 26 | 18 | 26 |
| Increased Fatigue | Psychiatric disorders | Non-systematic Assessment |
|
| Sleepiness | Psychiatric disorders | Non-systematic Assessment |
|
| Failed Memory | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Tension | Psychiatric disorders | Non-systematic Assessment |
|
| Increased Sleep | Psychiatric disorders | Non-systematic Assessment |
|
| Reduced Sleep | Psychiatric disorders | Non-systematic Assessment |
|
| Increased Dreams | Psychiatric disorders | Non-systematic Assessment |
|
| Emotional Indifference | Psychiatric disorders | Non-systematic Assessment |
|
| Dystonia | Nervous system disorders | Non-systematic Assessment |
|
| Rigidity | Nervous system disorders | Non-systematic Assessment |
|
| Hypokinesia | Nervous system disorders | Non-systematic Assessment |
|
| Hyperkinesia | Nervous system disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Akathesia | Nervous system disorders | Non-systematic Assessment |
|
| Epileptic Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesias | Nervous system disorders | Non-systematic Assessment |
|
| Accommodation Distance | Eye disorders | Non-systematic Assessment |
|
| Increased Salivation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Reduced Salivation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Micturition Distance | Renal and urinary disorders | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Polyps / Tachycardia | General disorders | Non-systematic Assessment |
|
| Increased Sweat | General disorders | Non-systematic Assessment |
|
| Rash | General disorders | Non-systematic Assessment |
|
| Pruritus | General disorders | Non-systematic Assessment |
|
| Photosensitivity | Eye disorders | Non-systematic Assessment |
|
| Increased Pigmentation | Eye disorders | Non-systematic Assessment |
|
| Weight Increase | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Weight Decrease | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Galactorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Increased Sexual Desire | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Diminished Sexual Desire | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Sexual Dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Tension Headache | General disorders | Non-systematic Assessment |
|
| Migraine Headache | General disorders | Non-systematic Assessment |
|
| Physical Dependence | General disorders | Non-systematic Assessment |
|
| Psychological Dependence | General disorders | Non-systematic Assessment |
|
| Other Headache | General disorders | Non-systematic Assessment |
|
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