Safety and Effectiveness of D-Serine in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00322023|
Recruitment Status : Unknown
Verified October 2008 by National Institute of Mental Health (NIMH).
Recruitment status was: Active, not recruiting
First Posted : May 4, 2006
Last Update Posted : October 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: D-serine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PK/PD Study of Escalating Dose D-Serine as Adjunctive Treatment in Schizophrenia|
|Study Start Date :||March 2006|
|Estimated Primary Completion Date :||June 2008|
|Estimated Study Completion Date :||June 2008|
Participants will receive treatment with D-serine
D-serine at following dose levels: 30 mg/kg, 60 mg/kg, and 120 mg/kg. PK/PD studies done at day 1. Medication will be administered as powder dissolved in liquid given in two divided doses daily for 4 weeks.
- Renal safety measures (serum, UA) [ Time Frame: Measured at Week 4 ]
- Positive and Negative Symptoms Scale (PANSS) [ Time Frame: Measured at Week 4 ]
- Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery [ Time Frame: Measured at Week 4 ]
- Clinical Global Impression (CGI) [ Time Frame: Measured at Week 4 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322023
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06512|
|United States, New York|
|The Zucker Hillside Hospital|
|Glen Oaks, New York, United States, 11004|
|The Nathan S. Kline Institute for Psychiatric Research|
|Orangeburg, New York, United States, 10962|
|Principal Investigator:||Daniel C. Javitt, MD, PhD||Nathan Kline Institute|