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Creatine as a Treatment Option for Depression in Methamphetamine Using Females

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ClinicalTrials.gov Identifier: NCT01514630
Recruitment Status : Completed
First Posted : January 23, 2012
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Perry Renshaw, University of Utah

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depression
Substance Abuse
Substance Use
Neuroimaging
Dual Diagnosis
Intervention Drug: Creatine monohydrate
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description 14 female depressed methamphetamine users received 5 grams of creatine monohydrate daily for eight weeks. Participants were seen twice weekly after creatine was initiated. All participants met SCID-I/P criteria for lifetime methamphetamine dependence or for current methamphetamine dependence. After consent was obtained, the principal investigator administered the SCID-I/P and HAMD, and if a female met SCID-I/P criteria and scored > 15 on the HAMD, the following additional screening data were collected: Beck Anxiety Inventory, C-SSRS , vital signs, concomitant medications, self-report drug use over the past 48 hours for cigarettes, alcohol, cocaine, methamphetamine, marijuana, heroin and prescription controlled substances, urine drug screen for methamphetamine, opiates, benzodiazepines, marijuana and cocaine, pregnancy testing and attendance in outpatient treatment and/or 12 step programs.
Period Title: Overall Study
Started 14
Completed 11
Not Completed 3
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description

14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.

Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks.

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 HAMD Rating Scores
Hide Description

Eight weeks of oral creatine supplementation will result in improvements in Hamilton Depression Rating Scale (HAMD) in female methamphetamine users. HAMD scoring is based on 17 items. Minimum score is 0 and maximum 52. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate or severe depression.

0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression

≥ 23 = Very Severe Depression

Time Frame Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description:

14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.

Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 16.86  (3.40)
week 2 10.71  (4.75)
week 3 9.81  (4.45)
week 4 7.33  (2.74)
week 5 8.35  (4.12)
week 6 7.73  (3.88)
week 7 6.28  (5.07)
week 8 7.36  (4.59)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Creatine Monohydrate
Hide Arm/Group Description

14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.

Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks.

All-Cause Mortality
Creatine Monohydrate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Creatine Monohydrate
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Creatine Monohydrate
Affected / at Risk (%)
Total   14/14 (100.00%) 
Gastrointestinal disorders   
Indigestion  1/14 (7.14%) 
Diarrhea  4/14 (28.57%) 
Stomach Discomfort  3/14 (21.43%) 
General disorders   
Cold and flu symptoms  10/14 (71.43%) 
Polydipsia  1/14 (7.14%) 
Headache  1/14 (7.14%) 
Swelling in Hands  1/14 (7.14%) 
Numbness and Tingling in hands  1/14 (7.14%) 
Muscle Cramps  2/14 (14.29%) 
Lightheaded  1/14 (7.14%) 
Nausea  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
Name/Title: Perry Renshaw, MD, PhD, MBA
Organization: The Brain Institute of the University of Utah
Phone: 801-587-1216
Responsible Party: Perry Renshaw, University of Utah
ClinicalTrials.gov Identifier: NCT01514630     History of Changes
Other Study ID Numbers: 60398
First Submitted: January 12, 2012
First Posted: January 23, 2012
Results First Submitted: May 14, 2015
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015