Status:
COMPLETED
Creatine Treatment for Female Adolescents With Depression Who Are Non-Responders to Fluoxetine or Escitalopram
Lead Sponsor:
University of Utah
Collaborating Sponsors:
AlzChem, LLC
Conditions:
Major Depressive Disorder
Eligibility:
FEMALE
13-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers. Creatine may have e...
Detailed Description
This is an open-label clinical trial of the investigational drug creatine, for augmentation treatment of female adolescents with Major Depressive Disorder (MDD) who have failed to respond to first-lin...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Major Depressive Disorder Participants:
- Participants must meet DSM-IV-TR criteria for Major Depressive Disorder, with current mood state depressed for ≥ 2 weeks.
- Participants must be females
- Participants must be between the age of 13 and 18 years.
- Participants must have had an adequate trial of fluoxetine, defined as a trial of ≥ 8 weeks of treatment, with a dose of ≥ 40mg daily for ≥ 4 weeks. If the participant had a trial of 40mg daily and was unable to tolerate it, a dose of 20mg for ≥ 8 weeks is acceptable; OR
- Participants must have had an adequate trial of escitalopram, defined as a trial of ≥ 8 weeks of treatment, with a dose of ≥ 20 mg daily for ≥ 4 weeks. If the participant had a trial of 20 mg daily and was unable to tolerate it, a dose of 10 mg for ≥ 8 weeks is acceptable.
- Participants must have a CDRS-R score of ≥ 40 and a CGI-S score of ≥ 4.
- Participants must be able to give informed consent or assent, and where applicable, parent(s)/guardian(s) must be able to give informed permission for study participation.
- Inclusion Criteria for Healthy Control Participants:
- Participants must be females
- Participants must be between the age of 13 and 18 years.
- Participants must not meet DSM-IV-TR diagnostic criteria for a psychiatric or substance abuse disorder.
- Participants must be able to give informed consent or assent and, where applicable, parent(s)/guardian(s) must be able to give informed permission for study participation.
- Exclusion Criteria for Treatment-Resistant Major Depressive Disorder Participants:
- Unstable co-morbid medical, neurological or psychiatric disorder.
- Pre-existing renal disease.
- Proteinuria or microalbuminuria.
- Pregnant females, nursing mothers, or females of childbearing potential who are unable or unwilling to practice birth control during the study. Participants who are of child-bearing potential must have a negative urine pregnancy test before each MRI/MRS brain scan.
- High risk for suicidal behavior, homicidal behavior or self-harm.
- Adolescents who are unlikely to be able to comply with the study protocol.
- DSM-IV-TR criteria for current substance abuse or substance dependence, with the exception of nicotine abuse or dependence.
- Contraindication to MRI/MRS brain scans, such as ferromagnetic implants or claustrophobic anxiety.
- Documented or suspected history of intellectual disability (Full-Scale I.Q. \< 70).
- History of hypersensitivity to creatine monohydrate.
- Exclusion Criteria for Healthy Controls:
- Clinically significant psychiatric or substance abuse disorder.
- Unstable medical or neurological illness.
- Pregnancy, due to the unknown effects of MRI/MRS scanning on a developing fetus.
- Females of childbearing potential who are unable or unwilling to practice contraception during the study.
- Positive urine pregnancy test.
- Contraindication to MRI/MRS scanning, such as ferromagnetic implant or claustrophobic anxiety.
- Documented or suspected history of mental retardation (Full-Scale I.Q. \< 70).
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00851006
Start Date
April 1 2009
End Date
December 1 2012
Last Update
May 12 2017
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108