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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
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study will determine whether increasing D-serine within the body will improve negative symptoms and cognitive impairments in people with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: D-serine Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Serine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Participants will receive treatment with D-serine
Drug: 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.


Outcome Measures

Primary Outcome Measures :
  1. Renal safety measures (serum, UA) [ Time Frame: Measured at Week 4 ]

Secondary Outcome Measures :
  1. Positive and Negative Symptoms Scale (PANSS) [ Time Frame: Measured at Week 4 ]
  2. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Battery [ Time Frame: Measured at Week 4 ]
  3. Clinical Global Impression (CGI) [ Time Frame: Measured at Week 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Structured Clinical Interview for DSM-III-R diagnosis of schizophrenia or schizoaffective disorder
  • PANSS 3 factor negative symptom inclusion score greater than 20 prior to study entry
  • PANSS total score between 60 and 110
  • Simpson-Angus Scale total score of 12 or less
  • Calgary Depression Inventory total score of 10 and suicide score less than 2
  • No change in Clinical Global Impressions (CGI) Scale score prior to study entry
  • Chlorpromazine (CPZ) equivalent of 1500 or less
  • Willing to use an effective form of birth control throughout the study if sexually active

Exclusion Criteria:

  • High extrapyramidal symptom (EPS) levels
  • Began, discontinued, or adjusted psychotropic medication within 2 weeks of study entry
  • Taking investigational medication within 2 weeks of study entry
  • Contraindication to study medication
  • Serious or unstable medical illness
  • Pregnant or breastfeeding
  • Alcohol or drug abuse within 6 months of study entry
  • Diagnosed with neurodegenerative disease or a seizure disorder
  • History of a kidney impairment
  • Currently taking clozapine
  • Currently taking more than two antipsychotic medications
  • Currently taking stimulants or cholinesterase inhibitors
Contacts and Locations

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Daniel C. Javitt, MD, PhD Nathan Kline Institute
More Information

Responsible Party: Daniel Javitt, Nathan Kline Institute
ClinicalTrials.gov Identifier: NCT00322023     History of Changes
Other Study ID Numbers: U01MH074356 ( U.S. NIH Grant/Contract )
DATR A5-EPTD
First Posted: May 4, 2006    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008

Keywords provided by National Institute of Mental Health (NIMH):
Negative symptoms
NMDA
Glutamate
Glycine

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