NCT02568878 Creatine for Depressed Male and Female Methamphetamine Users
| NCT ID | NCT02568878 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Montana State University |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2015-11 |
| Primary Completion | 2016-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 29 participants in total. It began in 2015-11 with a primary completion date of 2016-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users * Assess creatine's effect on methamphetamine use * Assess the safety of creatine in male methamphetamine users with depression
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Tracy Hellem, PhD
PRINCIPAL INVESTIGATOR
Montana State University
Frequently Asked Questions
Who can join the NCT02568878 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02568878 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 29 participants.
Is NCT02568878 currently recruiting?
Yes, NCT02568878 is actively recruiting participants. Contact the research team at tracy.hellem1@montana.edu for enrollment information.
Where is the NCT02568878 trial being conducted?
This trial is being conducted at Missoula, United States.
Who is sponsoring the NCT02568878 clinical trial?
NCT02568878 is sponsored by Montana State University. The principal investigator is Tracy Hellem, PhD at Montana State University. The trial plans to enroll 29 participants.
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