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Creatine as a New Therapeutic Strategy in Depression

This study has been terminated.
Sponsor:
Collaborator:
Beersheva Mental Health Center
Information provided by (Responsible Party):
Levine Yossi Prof., Herzog Hospital
ClinicalTrials.gov Identifier:
NCT00313417
First received: April 11, 2006
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

Creatine as a new therapeutic strategy in depression:

A double-blind, parallel, randomized, add-on clinical trial of creatine versus placebo added to antidepressant treatment of patients with major depressive episode.


Condition Intervention Phase
Major Depressive Disorder
 Dietary Supplement: Creatine monohydrate
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Parallel, Randomized, add-on Clinical Trial of Creatine Versus Placebo Added to Antidepressant Treatment of Patients With Major Depressive Episode.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herzog Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale, CGI [ Time Frame: 4 weeks of treatment for each subject ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Dietary Supplement: Creatine monohydrate
Up to 10 grams
Placebo Comparator: 2 Other: Placebo
Placebo will be given in the same way and appearance as the active treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age:18-75 -

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313417

Locations
Israel
Beer Sheva Mental Health Center
Beer Sheva, Israel
Sponsors and Collaborators
Herzog Hospital
Beersheva Mental Health Center
Investigators
Principal Investigator: Joseph Levine, Prof. Beer Sheva Mental Health Center Israel.
Principal Investigator: Boris Nemets, Dr. Beer Sheva Mental Health Center Israel.
  More Information

No publications provided

Responsible Party: Levine Yossi Prof., HEAD OF PSYCHIATRIC WARD, Herzog Hospital
ClinicalTrials.gov Identifier: NCT00313417     History of Changes
Other Study ID Numbers: Shapira1CTIL
Study First Received: April 11, 2006
Last Updated: April 3, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Herzog Hospital:
Creatine
major depressive disorders

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 17, 2013