Open-Label Creatine Study for Female Meth Users

• Sponsor: Perry Renshaw (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02189915
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 45
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Study Purposes and Objectives:

The objectives should be stated in such a way that the reader can determine the appropriateness of the study design. If appropriate, state the specific hypotheses being tested and/or study aims. Use lay language.

Methamphetamine use is of great concern in the state of Utah because it's the primary drug of threat in the state, and is the primary drug of choice among females between the ages of 18 and 24. 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 or Disease	Intervention/Treatment	Phase
Depression; Dual Diagnosis; Substance Use	Drug: Creatine monohydrate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Creatine monohydrate	Drug: Creatine monohydrate

Outcome Measures

Primary Outcome Measures

1. Depression Rating Scores [8-week]

   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.

Secondary Outcome Measures

1. Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy [8 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Inclusion criteria for healthy comparison group:

1. Must be female

2. Must be between the ages of 13 and 55 years

3. Must be able to give informed consent

Exclusion criteria for healthy comparison group:

1. Significant current medical illness

2. DSM-IV disorder identified by the SCID (to include bipolar I, bipolar II, bipolar NOS, major depressive disorder, dysthymia disorder, depressive disorder NOS, primary psychotic symptoms, substance use disorders, and anxiety disorders)

3. Known pregnancy or positive urine HCG test

4. Contraindication to an MR scan

5. Inability to comply with the protocol

6. Positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

• Perry Renshaw

Investigators

• Principal Investigator: Perry Renshaw, MD, PhD, MBA, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Perry Renshaw, Professor of Psychiatry, University of Utah
• ClinicalTrials.gov Identifier: NCT02189915
• Other Study ID Numbers: 53737
• First Posted: Jul 15, 2014
• Last Update Posted: May 20, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Creatine Monohydrate Treatment
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

Baseline Characteristics

Arm/Group Title	Creatine Monohydrate
Arm/Group Description	Creatine monohydrate
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.4 (9.9)
Sex: Female, Male (Count of Participants)
Female	14 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	Depression Rating Scores
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creatine Monohydrate Treatment
Arm/Group Description	This study is an open label study, where all participants received Creatine monohydrate.
Measure Participants	11
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Creatine Monohydrate Treatment
Arm/Group Description	This study is an open label study, where all participants received Creatine monohydrate.
Measure Participants	10
Baseline	0.223 (0.013)
Post-treatment	0.233 (0.009)

Adverse Events

Arm/Group Title	Creatine Monohydrate Treatment
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Creatine Monohydrate Treatment
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Creatine Monohydrate Treatment
	Affected / at Risk (%)	# Events
Total	14/14 (100%)
Eye disorders
Blurry vision	1/14 (7.1%)
Gastrointestinal disorders
Indigestion, Nausea	6/14 (42.9%)
General disorders
Flu like symptoms	13/14 (92.9%)
Swelling in hands	4/14 (28.6%)
Nervous system disorders
Numbness, tingling	1/14 (7.1%)

Limitations/Caveats

[Not Specified]

More Information

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.