Creatine Treatment in Psychiatric Disorders

NCT00140192 | Completed Phase 3

• 1 other identifier: BMHC-3835
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

creatine metabolism; schizophrenia; energy metabolism

Outcome Measures

Primary Outcomes (2)

• Positive and Negative Syndrome Scale

• Clincal Global Impression

Interventions

creatine DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• drug or alcohol abuse
• clinically significant medical condition
• laboratory abnormality

Sponsors & Collaborators

• Beersheva Mental Health Center: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Beersheva Mental Health Center

Beersheva, Israel

Location

Related Publications (1)

• Kaptsan A, Odessky A, Osher Y, Levine J. Lack of efficacy of 5 grams daily of creatine in schizophrenia: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007 Jun;68(6):881-4. doi: 10.4088/jcp.v68n0609.

  PMID: 17592912 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Creatine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• RH Belmaker, MD

  Ben Gurion University of the Negev + Beersheva Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: September 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: July 29, 2009

Record last verified: 2005-10

Locations

IL (1)