Israel Multicenter D-Serine Study (IMSER) for the Treatment of Schizophrenia

NCT ID: NCT00138775

Last Updated: 2006-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder

Keywords

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D-serine Negative symptoms Cognition Schizophrenia Amino acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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D-serine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Mark Weiser, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Mazra Mental Health Center

Acre, , Israel

Site Status RECRUITING

Ha-Emek Medical Center

Afula, , Israel

Site Status NOT_YET_RECRUITING

Abarbanel Mental Health Center

Bat Yam, , Israel

Site Status RECRUITING

Beer-Yaacov Mental Health Center

Beer-Yaacov, , Israel

Site Status RECRUITING

Shalvata Mental Health Center

Hod HaSharon, , Israel

Site Status RECRUITING

Kfar Shaul Psychiatric Hospital

Jerusalem, , Israel

Site Status RECRUITING

The Sarah Herzog Memorial Hospital

Jerusalem, , Israel

Site Status RECRUITING

Nes-Ziona Mental Health Center

Ness Ziona, , Israel

Site Status RECRUITING

Lev Hasharon Mental Health Center

Pardesiyya, , Israel

Site Status RECRUITING

Geha Mental Health Center

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Shaar Menashe Mental Health Center

Shaar Menashe, , Israel

Site Status NOT_YET_RECRUITING

Jaffa Mental Health Center

Tel Aviv, , Israel

Site Status RECRUITING

Maccabi Mental Health Center

Tel Aviv, , Israel

Site Status NOT_YET_RECRUITING

Countries

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Israel

Central Contacts

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Mark Weiser, MD

Role: CONTACT

Phone: ++972-352-6666575

Email: [email protected]

Facility Contacts

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David Liba, MD

Role: primary

Ilana Kremer, MD

Role: primary

Motti Mashiah, MD

Role: primary

Yehuda Abramovitch, MD

Role: primary

Yehiel Levkovitch, MD

Role: primary

Alexander Teitelbaum, MD

Role: primary

Uriel Heresco-Levy, MD

Role: primary

Daniela Amital, MD

Role: primary

Dimitri Rudinski, MD

Role: primary

Shai Konas, MD

Role: primary

Mark Weiser, MD

Role: primary

Shmuel Hirschmann, MD

Role: primary

Yosef Zimerman, MD

Role: primary

Yerechmiel Barber, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 22795211 (View on PubMed)

Other Identifiers

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SHEBA-03-3093-MW-CTIL

Identifier Type: -

Identifier Source: org_study_id