Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users

This study is currently recruiting participants.
Verified January 2013 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Perry Renshaw, University of Utah
ClinicalTrials.gov Identifier:
NCT01514630
First received: January 12, 2012
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

Methamphetamine (MA) use is of great concern in the state of Utah (UT) because it is the primary drug threat in the state, and accounts for 15.6% of substance abuse treatment admissions. It UT, MA is more widely abused than heroin, cocaine, or prescription drugs, and it's the primary drug of choice in females between the ages of 18 and 24 years. Depression among females is also a great concern in UT. Females are prescribed antidepressants at a rate of more than twice that of males. Consistent research findings have reported a prevalence of major depressive disorder (MDD) in female MA users as being two to three times greater than males. There are limited treatment options for treating MDD in female MA users. Limited studies of creatine monohydrate supplementation in adolescent females with MDD who have not responded to SSRI-treatment suggest that creatine is safe and reduces depressive symptoms, but there are no reports of creatine supplementation in depressed female MA users.

The primary hypothesis of the study is that eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female MA users. Secondary hypotheses include the following: 1) creatine supplementation will result in a decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral supplementation.


Condition Intervention Phase
Depression
Substance Abuse
Substance Use
Drug: Creatine monohydrate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Depression rating scores [ Time Frame: Over the course of eight weeks. Depression rating scores will be measured twice weekly for eight weeks for each subject enrolled. ] [ Designated as safety issue: No ]
    Eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female methamphetamine users.


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Creatine monohydrate
Twenty female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.
Drug: Creatine monohydrate
Five grams of creatine monohydrate will be administered for eight weeks.

  Eligibility

Ages Eligible for Study:   13 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Must be female
  2. Must be between the ages of 13 and 55 years
  3. Methamphetamine must be primary drug of choice
  4. Must have used methamphetamine within the last 6 months
  5. For participants > 18 years of age, must have a Hamilton Depression Rating Scale (HDRS or HAM-D) score of > 17
  6. For participants < 18 years of age, must have a Children Depression Rating Scale (CDRS) score of > 40
  7. Must be able to give informed consent

Exclusion Criteria:

  1. Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders
  2. DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
  3. Known pregnancy or positive urine HCG test
  4. Current serious homicidal or suicidal risk
  5. Young Mania Rating Scale (YMRS) score > 7
  6. Inability to comply with the protocol
  7. Contraindication to an MR scan
  8. Positive HIV test
  9. Known sensitivity to creatine monohydrate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514630

Contacts
Contact: Tracy Hellem, RN 801-587-1546 tracy.hellem@hsc.utah.edu

Locations
United States, Utah
The Brain Institute of the University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Tracy Hellem, RN    801-587-1456    tracy.hellem@hsc.utah.edu   
Sponsors and Collaborators
Perry Renshaw
Investigators
Principal Investigator: Perry Renshaw, MD, PhD, MBA The Brain Institute of the University of Utah
  More Information

No publications provided

Responsible Party: Perry Renshaw, Professor of Psychiatry, University of Utah
ClinicalTrials.gov Identifier: NCT01514630     History of Changes
Other Study ID Numbers: Creatine Methamphetamine
Study First Received: January 12, 2012
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Substance-Related Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Methamphetamine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014