Clinical trial NCT00138775: Israel Multicenter D-Serine Study (IMSER) for the Treatment of Schizophrenia
Official title: D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: D-serine
Negative symptoms
Cognition
Schizophrenia
Amino acid
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Stanley Medical Research Institute
First posted: 2005-08-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the present study is to evaluate the effect of D-serine, added to antipsychotic treatment, on negative and cognitive symptoms in schizophrenia.

The investigators are hypothesizing that D-serine will improve cognitive functioning and negative symptoms.


Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) diagnosis of schizophrenia and\\or schizoaffective disorder.
* Age between 18 to 64.
* PANSS negative symptom score higher than 19.
* SAS total score lower than 12.
* CDSS suicidal risk lower than 2

Exclusion Criteria:

* Epilepsy
* Meets DSM-IV criteria for mental retardation.
* Medical condition which confounds presentation or treatment (e.g. uncontrolled diabetes mellitus, history of kidney stones, acute drug toxicity, dementia, delirium, stroke, etc.)
* Meets DSM-IV criteria for alcohol or drug dependence in last 6 months.
* Meets DSM-IV criteria for alcohol or drug abuse in last one month.
* Treatment with clozapine.
* Current positive pregnancy test or not using acceptable method of birth control.
* Meets DSM-IV criteria for current anxiety or mood disorders

Primary outcomes:
measure: SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16
measure: Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16
Secondary outcomes:
measure: Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16
measure: Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16
measure: Clinical Global Impressions (CGI) score - weeks 0, 8 and 16
measure: Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16
measure: Side effect check list
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha-Emek Medical Center
city: Akko
country: Israel
facility: Mazra Mental Health Center
city: Bat Yam
country: Israel
facility: Abarbanel Mental Health Center
city: Beer-Yaacov
country: Israel
facility: Beer-Yaacov Mental Health Center
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
city: Jerusalem
country: Israel
facility: Kfar Shaul Psychiatric Hospital
city: Jerusalem
country: Israel
facility: The Sarah Herzog Memorial Hospital
city: Nes Ziona
country: Israel
facility: Nes-Ziona Mental Health Center
city: Pardesiyya
country: Israel
facility: Lev Hasharon Mental Health Center
city: Petah Tiqwa
country: Israel
facility: Geha Mental Health Center
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Shaar Menashe
country: Israel
facility: Shaar Menashe Mental Health Center
city: Tel Aviv
country: Israel
facility: Jaffa Mental Health Center
city: Tel Aviv
country: Israel
facility: Maccabi Mental Health Center
Study officials:
affiliation: Sheba Medical Center
name: Mark Weiser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiser M, Heresco-Levy U, Davidson M, Javitt DC, Werbeloff N, Gershon AA, Abramovich Y, Amital D, Doron A, Konas S, Levkovitz Y, Liba D, Teitelbaum A, Mashiach M, Zimmerman Y. A multicenter, add-on randomized controlled trial of low-dose d-serine for negative and cognitive symptoms of schizophrenia. J Clin Psychiatry. 2012 Jun;73(6):e728-34. doi: 10.4088/JCP.11m07031.