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Creatine Treatment for Female Adolescents With Depression Who Are Non-Responders to Fluoxetine or Escitalopram

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ClinicalTrials.gov Identifier: NCT00851006
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : January 13, 2015
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
AlzChem, LLC
Information provided by (Responsible Party):
Douglas Kondo, MD, University of Utah

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: Creatine Monohydrate
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label Creatine Treatment Healthy Control Group
Hide Arm/Group Description Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks. Only 31P MRS brain scans were used from healthy individuals. HC group were not treated.
Period Title: Overall Study
Started 7 6
Completed 7 6
Not Completed 0 0
Arm/Group Title Open Label Creatine Treatment
Hide Arm/Group Description Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks. Inclusion criteria were: females 13–18 years of age with a primary diagnosis of MDD. All participants were Caucasian females.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Age Number Analyzed 7 participants
15.6
(14 to 18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
7
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
7
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Mean Children's Depression Rating Scale (CDRS-R) [Reference: Poznanski EO et al. Preliminary Studies of the Reliability and Validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984 Mar;23(2):191-7.]
Hide Description The CDRS-R is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not assessed in the "Healthy Controls". Only subjects in treatment group were evaluated with CDRS-R and received scores.
Arm/Group Title Open Label Creatine Treatment
Hide Arm/Group Description:
The seven subjects who completed the protocol received creatine in the 1-8 week interval. Creatine was initiated at week 0 and terminated at week 8.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 69  (9.69)
After 8 week Creatine treatment 30.6  (8.5)
2.Secondary Outcome
Title 31-phosphorus Magnetic Resonance Spectroscopy Phosphocreatine Metabolite
Hide Description Phosphocreatine Metabolite is a phosphorylated creatine molecule that plays a role in the production of the energy in the body. Phosphocreatine (PCr) metabolite was quantified by calculating the ratio of PCr over total phosphorus resonance from 31-Phosphorus Magnetic Resonance Spectroscopy.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Creatine Treatment Healthy Control Group
Hide Arm/Group Description:

MDD participants' 31P MRS scans were performed prior to the first dose of creatine, and repeated following 8 weeks of treatment.

Participants were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks.

6 healthy controls returned 8 weeks later for a follow-up scan. HC group did not receive any treatment.
Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: ratio of PCr and total phosphorus
Baseline 0.1513  (0.0137) 0.1556  (0.0086)
After 8 weeks 0.1610  (0.0165) 0.1558  (0.0154)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label Creatine Treatment Healthy Control Group
Hide Arm/Group Description There were no serious adverse events were experienced in this study. Healthy Control Group did not go through treatment. HC 31P MRS scans were only used for the study.
All-Cause Mortality
Open Label Creatine Treatment Healthy Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Creatine Treatment Healthy Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label Creatine Treatment Healthy Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      0/6 (0.00%)    
Gastrointestinal disorders     
Gastrointestinal issues  5/7 (71.43%)  6 0/6 (0.00%) 
General disorders     
Headache, flu-like symptoms, epistaxis, allergies  3/7 (42.86%)  9 0/6 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle spasm  1/7 (14.29%)  1 0/6 (0.00%) 
Nervous system disorders     
Intermittent tremors  1/7 (14.29%)  1 0/6 (0.00%) 
Psychiatric disorders     
Suicidal ideation  1/7 (14.29%)  1 0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory issues  5/7 (71.43%)  5 0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Douglas Kondo, M.D.
Organization: University of Utah
Phone: 801-587-1549
EMail: doug.kondo@hsc.utah.edu
Layout table for additonal information
Responsible Party: Douglas Kondo, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00851006     History of Changes
Other Study ID Numbers: 33465
First Submitted: February 23, 2009
First Posted: February 25, 2009
Results First Submitted: December 9, 2014
Results First Posted: January 13, 2015
Last Update Posted: May 12, 2017