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Creatine as a New Therapeutic Strategy in Depression

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00313417
First Posted: April 12, 2006
Last Update Posted: April 5, 2013
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.
Collaborator:
Beersheva Mental Health Center
Information provided by (Responsible Party):
Levine Yossi Prof., Herzog Hospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Levine Yossi Prof., Herzog Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale, CGI [ Time Frame: 4 weeks of treatment for each subject ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age:18-75 -

Exclusion Criteria:

  Contacts and Locations
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): 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

Responsible Party: Levine Yossi Prof., HEAD OF PSYCHIATRIC WARD, Herzog Hospital
ClinicalTrials.gov Identifier: NCT00313417     History of Changes
Other Study ID Numbers: Shapira1CTIL
First Submitted: April 11, 2006
First Posted: April 12, 2006
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by Levine Yossi Prof., Herzog Hospital:
Creatine
major depressive disorders

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