Creatine as a New Therapeutic Strategy in Depression - Full Text View

Sponsors and Collaborators:	Herzog Hospital Beersheva Mental Health Center
Information provided by:	Herzog Hospital
ClinicalTrials.gov Identifier:	NCT00313417

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 IV

MedlinePlus related topics: Antidepressants Depression Mental Health

Drug Information available for: Creatine Creatine monohydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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.

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 ]

Estimated Enrollment:	40
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Dietary Supplement: Creatine monohydrate Up to 10 grams
2: Placebo Comparator	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 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age:18-70 -

Exclusion Criteria:

-

Contacts and Locations

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

Locations

Israel
Herzog Hospital	Withdrawn
Jerusalem, Israel, 91035
Beer Sheva Mental Health Center	Recruiting
Beer Sheva, Israel
Contact: Boris nemetz, Dr nemetz@bgu.ac.il
Principal Investigator: Boris Nemets, Dr.
Principal Investigator: Joseph Levine, Prof.

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:	Beersheva Mental Health Center/ Ben Gurion University of The Negev, Israel ( Nemets Boris and Levine Joseph, Beersheva Mental Health Center, Israel )
Study ID Numbers:	Shapira1CTIL
Study First Received:	April 11, 2006
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00313417
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Herzog Hospital:

Creatine
major depressive disorders

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009