Recruiting PHASE3 Depression

New treatment option for Depression

Official title Creatine for Depressed Male and Female Methamphetamine Users

ClinicalTrials.gov ID: NCT02568878

What this study is testing

What is Creatine monohydrate?

Creatine monohydrate is an investigational medicine, being studied as a potential treatment for depression.

Also referred to as Creapure.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 59

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Missoula, Montana, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 59 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Missoula, Montana, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.