Israel Multicenter D-Serine Study (IMSER) for the Treatment of Schizophrenia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00138775 |
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Recruitment Status
: Unknown
Verified October 2006 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted
: August 30, 2005
Last Update Posted
: December 27, 2006
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Sponsor:
Sheba Medical Center
Collaborator:
Stanley Medical Research Institute
Information provided by:
Sheba Medical Center
- Study Details
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- No Results Posted
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Schizoaffective Disorder | Drug: D-serine | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia |
| Study Start Date : | October 2004 |
| Study Completion Date : | October 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Serine
U.S. FDA Resources
Primary Outcome Measures
:
- SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16
- Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16
Secondary Outcome Measures
:
- Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16
- Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16
- Clinical Global Impressions (CGI) score - weeks 0, 8 and 16
- Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16
- Side effect check list
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT00138775
Contacts
| Contact: Mark Weiser, MD | ++972-352-6666575 | mweiser@netvision.net.il |
Locations
| Israel | |
| Ha-Emek Medical Center | Not yet recruiting |
| Afula, Israel | |
| Contact: Ilana Kremer, MD ++972-46494350 kremer@aviv-pcb.com | |
| Principal Investigator: Ilana Kremer, MD | |
| Mazra Mental Health Center | Recruiting |
| Akko, Israel | |
| Contact: David Liba, MD ++972-49559644 dliba1@netvision.net.il | |
| Principal Investigator: David Liba, MD | |
| Abarbanel Mental Health Center | Recruiting |
| Bat Yam, Israel | |
| Contact: Motti Mashiah, MD ++972-35552604 | |
| Principal Investigator: Motti Mashiah, MD | |
| Beer-Yaacov Mental Health Center | Recruiting |
| Beer-Yaacov, Israel | |
| Contact: Yehuda Abramovitch, MD ++972-89258221 byabramovitch@beer-ness.health.gov.il | |
| Principal Investigator: Yehuda Abramovitch, MD | |
| Shalvata Mental Health Center | Recruiting |
| Hod Hasharon, Israel | |
| Contact: Yehiel Levkovitch, MD ++972-97478568 ylev@clalit.org.il | |
| Principal Investigator: Yehiel Levkovitch, MD | |
| Kfar Shaul Psychiatric Hospital | Recruiting |
| Jerusalem, Israel | |
| Contact: Alexander Teitelbaum, MD ++972-26448780 teital@barak-online.net | |
| Principal Investigator: Alexander Teitelbaum, MD | |
| The Sarah Herzog Memorial Hospital | Recruiting |
| Jerusalem, Israel | |
| Contact: Uriel Heresco-Levy, MD ++972-25316906 heresco@md2.huji.ac.il | |
| Principal Investigator: Uriel Heresco-L | |
| Nes-Ziona Mental Health Center | Recruiting |
| Nes Ziona, Israel | |
| Contact: Daniela Amital, MD ++972-50-8647067 | |
| Principal Investigator: Daniela Amital, MD | |
| Lev Hasharon Mental Health Center | Recruiting |
| Pardesiyya, Israel | |
| Contact: Dimitri Rudinski, MD ++972-98981210 drudinski@lev-hasaron.co.il | |
| Principal Investigator: Dimitri Rudinski, MD | |
| Geha Mental Health Center | Recruiting |
| Petah Tiqwa, Israel | |
| Contact: Shai Konas, MD ++972-50-7215226 konass@clalit.org.il | |
| Principal Investigator: Shai Konas, MD | |
| Sheba Medical Center | Recruiting |
| Ramat-Gan, Israel | |
| Contact: Mark Weiser, MD ++972-52-6666576 mweiser@netvision.net.il | |
| Principal Investigator: Mark Weiser, MD | |
| Shaar Menashe Mental Health Center | Not yet recruiting |
| Shaar Menashe, Israel | |
| Contact: Shmuel Hirschmann, MD hirscmann@shaar-menashe.org.il | |
| Principal Investigator: Shmuel Hirschman, MD | |
| Jaffa Mental Health Center | Recruiting |
| Tel Aviv, Israel | |
| Contact: Yosef Zimerman, MD ++972-35151117 zimermanj@yahoo.com | |
| Principal Investigator: Yosef Zimerman, MD | |
| Maccabi Mental Health Center | Not yet recruiting |
| Tel Aviv, Israel | |
| Contact: Yerechmiel Barber, MD ++972-35122196 ybarber@hotmail.co.il | |
| Principal Investigator: Yerechmiel Barber, MD | |
Sponsors and Collaborators
Sheba Medical Center
Stanley Medical Research Institute
Investigators
| Principal Investigator: | Mark Weiser, MD | Sheba Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00138775 History of Changes |
| Other Study ID Numbers: |
SHEBA-03-3093-MW-CTIL |
| First Posted: | August 30, 2005 Key Record Dates |
| Last Update Posted: | December 27, 2006 |
| Last Verified: | October 2006 |
Keywords provided by Sheba Medical Center:
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D-serine Negative symptoms Cognition Schizophrenia Amino acid |
Additional relevant MeSH terms:
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Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |