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| Descriptive Information Fields | |||||||||
| Brief Title † | Safety and Effectiveness of D-Serine in Schizophrenia | ||||||||
| Official Title † | PK/PD Study of Escalating Dose D-Serine as Adjunctive Treatment in Schizophrenia | ||||||||
| Brief Summary | This study will determine whether increasing D-serine within the body will improve negative symptoms and cognitive impairments in people with schizophrenia. |
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| Detailed Description | Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, believe that others are controlling their thoughts, and even fail at maintaining a job or caring for themselves. Current medications help to relieve most of these symptoms, but not all. Some people with schizophrenia still suffer from negative symptoms, such as difficulty with talking, expressing emotions, and motivation; they may also suffer from cognitive impairments, such as decreased concentration and memory loss. D-serine, an amino acid found within the body, activates brain cell receptors that appear to play a role in learning and memory. This study will determine whether adding a D-serine solution to a stable antipsychotic medication regimen will decrease negative symptoms in people with schizophrenia. Participants in this open-label study will remain on their regular medication regimen for at least 2 weeks. During this time and before starting treatment, participants will be interviewed about their emotional problems, marital status, education, family background, employment history, and any drug or alcohol problems. Participants will also undergo a physical exam, an electrocardiogram (EKG), vital sign measurements, psychological tests, cognitive tasks, and an electroencephalogram (EEG). Participants will then begin 4 weeks of treatment with D-serine. In addition to participants' regular medication regimen, they will drink a D-serine powder mixed with water twice daily. Every 2 weeks, participants will undergo a physical exam and an interview about any changes in symptoms or emotional problems that they may be experiencing. Blood and urine samples will be taken throughout the study. After 4 weeks, participants will undergo an EKG, EEG, and the same psychological tests and cognitive tasks completed prior to treatment. A follow-up visit will occur 2 weeks post-treatment to monitor any changes in negative symptoms. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Renal safety measures (serum, UA) [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | Positive and Negative Symptoms Scale (PANSS) [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ] Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ] Clinical Global Impression (CGI) [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ] |
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| Condition † | Schizophrenia | ||||||||
| Intervention † | Drug: D-serine | ||||||||
| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 20 | ||||||||
| Start Date † | March 2006 | ||||||||
| Completion Date | June 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00322023 | ||||||||
| Organization ID | U01 MH074356 | ||||||||
| Secondary IDs †† | DATR A5-EPTD | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | February 2008 | ||||||||
| First Received Date † | May 2, 2006 | ||||||||
| Last Updated Date | February 28, 2008 | ||||||||
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