Title
Creatine for Depressed Male and Female Methamphetamine Users
An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users
Phase
Phase 3Lead Sponsor
Montana State UniversityStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Depression Anxiety Methamphetamine DependenceIntervention/Treatment
creatine ...Study Participants
29Assess 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
5 grams of daily creatine monohydrate by mouth for 8 weeks
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
