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Creatine as a New Therapeutic Strategy in Depression

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ClinicalTrials.gov Identifier: NCT00313417
Recruitment Status : Terminated
First Posted : April 12, 2006
Last Update Posted : April 5, 2013
Sponsor:
Collaborator:
Beersheva Mental Health Center
Information provided by (Responsible Party):
Levine Yossi Prof., Herzog Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Major Depressive Disorder Dietary Supplement: Creatine monohydrate Other: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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.
Study Start Date : January 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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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:


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.

Responsible Party: Levine Yossi Prof., HEAD OF PSYCHIATRIC WARD, Herzog Hospital
ClinicalTrials.gov Identifier: NCT00313417     History of Changes
Other Study ID Numbers: Shapira1CTIL
First Posted: April 12, 2006    Key Record Dates
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