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Open-Label Creatine Study for Female Meth Users

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ClinicalTrials.gov Identifier: NCT02189915
Recruitment Status : Terminated (Received funding for the next phase of the study)
First Posted : July 15, 2014
Results First Posted : May 20, 2016
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
Perry Renshaw, University of Utah

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depression
Dual Diagnosis
Substance Use
Intervention Drug: Creatine monohydrate
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Creatine Monohydrate Treatment
Hide Arm/Group Description This study is an open label study, where all participants received Creatine monohydrate.
Period Title: Overall Study
Started 14
Completed 11
Not Completed 3
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description Creatine monohydrate
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
37.4  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Depression Rating Scores
Hide Description Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.
Time Frame 8-week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine Monohydrate Treatment
Hide Arm/Group Description:
This study is an open label study, where all participants received Creatine monohydrate.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 16.86  (3.40)
After 8 weeks of treatment 7.36  (4.59)
2.Secondary Outcome
Title Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy
Hide Description Phosphocreatine (PCr) was measured pre- and post-creatine treatment to assess changes in neurochemistry. Creatine treatment may increase brain intracellular PCr, and brain energy metabolism has been suggested to play a role in the pathophysiology of depression. Increased levels of PCr suggest reduced depressive symptoms. PCr levels are calculated using a ratio and remains unitless.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine Monohydrate Treatment
Hide Arm/Group Description:
This study is an open label study, where all participants received Creatine monohydrate.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Phosphocreatine levels (unitless)
Baseline 0.223  (0.013)
Post-treatment 0.233  (0.009)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Creatine Monohydrate Treatment
Hide Arm/Group Description This study is an open label study, where all participants received Creatine monohydrate.
All-Cause Mortality
Creatine Monohydrate Treatment
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Creatine Monohydrate Treatment
Affected / at Risk (%)
Total   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Creatine Monohydrate Treatment
Affected / at Risk (%)
Total   14/14 (100.00%) 
Eye disorders   
Blurry vision  1/14 (7.14%) 
Gastrointestinal disorders   
Indigestion, Nausea  6/14 (42.86%) 
General disorders   
Flu like symptoms  13/14 (92.86%) 
Swelling in hands  4/14 (28.57%) 
Nervous system disorders   
Numbness, tingling  1/14 (7.14%) 
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: Perry Renshaw, MD, PhD, MBA
Organization: The Brain Institute of the University of Utah
Phone: 801-587-1216
EMail: perry.renshaw@hsc.utah.edu
Layout table for additonal information
Responsible Party: Perry Renshaw, University of Utah
ClinicalTrials.gov Identifier: NCT02189915    
Other Study ID Numbers: 53737
First Submitted: July 11, 2014
First Posted: July 15, 2014
Results First Submitted: February 16, 2016
Results First Posted: May 20, 2016
Last Update Posted: May 20, 2016