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SchizophreniaPhase 2NCT00138775

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

A Phase 2 study testing D-serine in people with Schizophrenia and Schizoaffective Disorder, run by Sheba Medical Center at 14 sites in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Schizophrenia, Schizoaffective Disorder
What is being tested?
D-serine
How many people
200 participants
Where
14 sitesIsrael
Study dates
Oct 2004to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

Mark Weiser, MD contact

++972-352-6666575

mweiser@netvision.net.il

14 sites in 1 country

Israel14 sites, 14 recruiting

  • Mazra Mental Health Center

    Acre

    David Liba, MD, ++972-49559644, dliba1@netvision.net.il

    David Liba, MD

    Recruiting

  • Ha-Emek Medical Center

    Afula

    Ilana Kremer, MD, ++972-46494350, kremer@aviv-pcb.com

    Ilana Kremer, MD

    Not yet recruiting

  • Abarbanel Mental Health Center

    Bat Yam

    Motti Mashiah, MD, ++972-35552604

    Motti Mashiah, MD

    Recruiting

  • Beer-Yaacov Mental Health Center

    Beer-Yaacov

    Yehuda Abramovitch, MD, ++972-89258221, byabramovitch@beer-ness.health.gov.il

    Yehuda Abramovitch, MD

    Recruiting

  • Shalvata Mental Health Center

    Hod HaSharon

    Yehiel Levkovitch, MD, ++972-97478568, ylev@clalit.org.il

    Yehiel Levkovitch, MD

    Recruiting

  • Kfar Shaul Psychiatric Hospital

    Jerusalem

    Alexander Teitelbaum, MD, ++972-26448780, teital@barak-online.net

    Alexander Teitelbaum, MD

    Recruiting

  • The Sarah Herzog Memorial Hospital

    Jerusalem

    Uriel Heresco-Levy, MD, ++972-25316906, heresco@md2.huji.ac.il

    Uriel Heresco-L

    Recruiting

  • Nes-Ziona Mental Health Center

    Ness Ziona

    Daniela Amital, MD, ++972-50-8647067

    Daniela Amital, MD

    Recruiting

  • Lev Hasharon Mental Health Center

    Pardesiyya

    Dimitri Rudinski, MD, ++972-98981210, drudinski@lev-hasaron.co.il

    Dimitri Rudinski, MD

    Recruiting

  • Geha Mental Health Center

    Petah Tikva

    Shai Konas, MD, ++972-50-7215226, konass@clalit.org.il

    Shai Konas, MD

    Recruiting

  • Sheba Medical Center

    Ramat Gan

    Mark Weiser, MD, ++972-52-6666576, mweiser@netvision.net.il

    Mark Weiser, MD

    Recruiting

  • Shaar Menashe Mental Health Center

    Shaar Menashe

    Shmuel Hirschmann, MD, hirscmann@shaar-menashe.org.il

    Shmuel Hirschman, MD

    Not yet recruiting

  • Jaffa Mental Health Center

    Tel Aviv

    Yosef Zimerman, MD, ++972-35151117, zimermanj@yahoo.com

    Yosef Zimerman, MD

    Recruiting

  • Maccabi Mental Health Center

    Tel Aviv

    Yerechmiel Barber, MD, ++972-35122196, ybarber@hotmail.co.il

    Yerechmiel Barber, MD

    Not yet recruiting

Other trials in Israel

About this study

Official title: D-Serine Adjuvant Pharmacotherapy for the Treatment of Schizophrenia

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.

Being tested
D-serine
Keywords
D-serine, Negative symptoms, Cognition, Schizophrenia, Amino acid
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D-serineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16

  2. Measurement and Treatment Research for Cognition in Schizophrenia (MATRICS) battery - visit weeks 0, 8 and 16

Secondary outcomes (5)

  1. Positive and Negative Syndrome Scale of Schizophrenia (PANSS) positive, negative, general and total score - weeks 0, 8 and 16

  2. Simpson-Angus Scale (SAS) total score - weeks 0, 8 and 16

  3. Clinical Global Impressions (CGI) score - weeks 0, 8 and 16

  4. Calgary Depression Scale for Schizophrenia (CDSS) score - weeks 0, 8 and 16

  5. Side effect check list

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2005 (estimated)
  2. Study startOct 2004
  3. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00138775
Sponsor's protocol ID
SHEBA-03-3093-MW-CTIL
Status last verified
Oct 2006
First submitted
28 Aug 2005
Last updated
27 Dec 2006
Results posted
No

Publications

  • 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.

    PubMed 22795211

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing D-serine in people with Schizophrenia and Schizoaffective Disorder, run by Sheba Medical Center at 14 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mark Weiser, MD (++972-352-6666575, mweiser@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SANS - Scale for the Assessment of Negative Symptoms - weeks 0, 8 and 16. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00138775, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2006; AzTrials last refreshed its copy on 6 Nov 2026.

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