NCT00313417

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4 major-depressive-disorder

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

3.9 years

First QC Date

April 11, 2006

Last Update Submit

April 3, 2013

Conditions

Major Depressive Disorder

Keywords

Creatinemajor depressive disorders

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale, CGI

    4 weeks of treatment for each subject

Study Arms (2)

1

ACTIVE COMPARATOR
Dietary Supplement: Creatine monohydrate

2

PLACEBO COMPARATOR
Other: Placebo

Interventions

Creatine monohydrateDIETARY_SUPPLEMENT

Up to 10 grams

1
PlaceboOTHER

Placebo will be given in the same way and appearance as the active treatment

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age:18-75 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beer Sheva Mental Health Center

Beersheba, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Creatine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Joseph Levine, Prof.

    Beer Sheva Mental Health Center Israel.

    PRINCIPAL INVESTIGATOR

  • Boris Nemets, Dr.

    Beer Sheva Mental Health Center Israel.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HEAD OF PSYCHIATRIC WARD

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

IL(1)