Creatine for Depression and Anxiety in Methamphetamine Users

This study is looking at whether creatine monohydrate can help men and women who use methamphetamine and also experience depression and anxiety. Researchers want to see if creatine can improve symptoms of depression and anxiety, and also affect methamphetamine use. You might be able to join if you are between 18 and 59 years old, have a diagnosis of methamphetamine dependence or abuse, and also have major depressive disorder and an anxiety disorder. To be eligible, your Hamilton Depression Rating Scale (HAMD) score must be 16 or higher, and your Hamilton Anxiety Scale (HAMA) score must also meet a certain level. The study will measure changes in your HAMD and HAMA scores to see if creatine is helpful. The current status of this study is unclear.

Study design
This interventional study plans to enroll 29 participants. It is not specified if the study is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your depression and anxiety scores will be assessed after 12 participants complete the study, again after 24 participants complete, and at study completion (anticipated 12 months after the study starts).

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NCT02568878

Creatine for Depressed Male and Female Methamphetamine Users

Recruiting
PHASE3Ages 18–59InterventionalTreatment
Montana State University
~29 participants
Updated 2015-12-11 on ClinicalTrials.gov
What's tested:Creatine monohydrate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hamilton Depression Rating Scale (HAMD) Scores
Measured over This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
+1 more outcome measured
Depression
Anxiety
Methamphetamine Dependence
1 sites across 1 states
Montana1
  • Tracy Hellem, PhD · PRINCIPAL_INVESTIGATOR · Montana State University

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Eligibility criteria

Inclusion

Current primary diagnosis of methamphetamine dependence or abuse, with methamphetamine preferred drug of abuse
Current diagnosis of major depressive disorder (primary or substance-induced)
Current diagnosis of an anxiety disorder (primary or substance-induced)
Current Hamilton Depression Rating scale score \> or = to 16
Current Hamilton Anxiety Scale score \> = to 18
If taking a psychotropic medication for depressed or anxious mood, regimen must be stable for \> = to 4 weeks prior to creatine treatment initiation

Exclusion

Persons unable to provide adequate informed consent
Persons who are at clinically significant suicidal or homicidal risk
Primary substance-related diagnosis other than methamphetamine dependence or abuse
Positive pregnancy test (females only)
History of renal disease
Clinically significant medical or neurological illness identified by history, physical exam and laboratory testing
History of hypersensitivity reaction to creatine
  • Hamilton Depression Rating Scale (HAMD) ScoresThis data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).
  • Hamilton Anxiety Rating Scale (HAMA) ScoresThis data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation).