Creatine Treatment in Psychiatric Disorders

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00140192
First received: August 31, 2005
Last updated: July 28, 2009
Last verified: October 2005
  Purpose

Creatine plays a pivotal role in brain energy homeostasis. Creatine supplementation is widely used in enhancing sports performance, and has been tried in the treatment of neurological, neuromuscular and atherosclerotic disease with a paucity of side effects.

Dechent et al (1999) studied the effect of oral creatine supplementation for 4 wk demonstrating a statistically significant increase of mean concentration of total creatine across brain regions. These findings suggest the possibility of using oral creatine supplementation to modify brain high-energy phosphate metabolism in subjects with various brain disorders, including schizophrenia and major depression. Recently, Rae et al (2003) reported that creatine supplementation for 6 weeks had a significant positive effect on both working memory and Raven matrices. Several independent lines of evidence suggest the possible involvement of altered cerebral energy metabolism in schizophrenia.

We are performing a double blind cross-over study of creatine in schizophrenia.

Forty patients will be treated with creatine for 3 months in a double-blind crossover design. Rating scales will include scales for assessing negative and positive symptoms of schizophrenia, clinical global impressions scale, scales for side-effects and a cognitive battery

Creatine effects on brain energy metabolism and its possible cognitive enhancing properties raise the possibility of developing a new therapeutic strategy in schizophrenia focusing on treating metabolic hypoactive brain areas including frontal regions.


Condition Intervention Phase
Schizophrenia
Drug: creatine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Creatine as a New Treatment for Schizophrenia:A Double-Blind Trial

Resource links provided by NLM:


Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale [ Designated as safety issue: No ]
  • Clincal Global Impression

Enrollment: 12
Study Start Date: September 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-60
  • physically healthy
  • at least 2 years of illness in a stable condition
  • presenting negative and cognitive symptoms

Exclusion Criteria:

  • drug or alcohol abuse
  • clinically significant medical condition
  • laboratory abnormality
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00140192

Locations
Israel
Beersheva Mental Health Center
Beersheva, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
National Alliance for Research on Schizophrenia and Depression
Investigators
Study Director: RH Belmaker, MD Ben Gurion University of the Negev + Beersheva Mental Health Center
  More Information

No publications provided by Beersheva Mental Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00140192     History of Changes
Other Study ID Numbers: BMHC-3835
Study First Received: August 31, 2005
Last Updated: July 28, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:
creatine metabolism
schizophrenia
energy metabolism

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014