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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 20, 2014