Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression
This study is not yet open for participant recruitment.
Verified July 2012 by University of Sao Paulo
Sponsor:
University of Sao Paulo
Information provided by (Responsible Party):
Ricardo Alexandre Toniolo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01655030
First received: July 29, 2012
Last updated: July 31, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar I Disorder Current Episode Depressed |
Dietary Supplement: creatine monohydrate Dietary Supplement: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Creatine Monohydrate as Adjunctive Therapy in the Treatment of Bipolar Depression |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- MADRS (Montgomery-Asberg depression Rating Scale) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- HDRS-17 (Hamilton Depression Rating Scale - 17-item version) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Other Outcome Measures:
- CGI (Clinical Global Impressions Scale) - Severity and Improvement [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- YMRS (Young Mania Rating Scale) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: creatine monohydrate
1,5g 2 caps bid
|
Dietary Supplement: creatine monohydrate |
|
Placebo Comparator: placebo
1,5g 2 caps bid
|
Dietary Supplement: placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Individuals eligible for the study will be adults aged 18 to 60 years of age who met DSM-IV criteria assessed by the SCID (Structural Clinical Interview for DSM-IV) for type I bipolar disorder, current episode depressed.
- Patients who have scored > 19 on the Montgomery-Asberg Depression Rating Scale (MADRS) will be included, although more than two weeks of treatment with lithium (serum level> 0.8 mEq / L), valproate (serum levels> 50 mg / L) or quetiapine (300-600mg/dia dose) or drug combination.
- Antipsychotics, anticonvulsants, benzodiazepines, and thyroid supplementation will be allowed if the dose has remained stable over the past two weeks.
- Antidepressants will be allowed if the dosage has remained stable for 4 weeks.
Exclusion Criteria:
- Subjects with substance abuse within 2 weeks before inclusion or substance dependence up to 2 months will not be included.
Other exclusion criteria will be:
- diagnosis of schizophrenia,
- dementia,
- delirium,
- epilepsy,
- mental retardation,
- clinically unstable medical illnesses,
- preexisting renal disease,
- history of hypersensibility to creatine.
- Not included are individuals at high risk for suicidal or homicidal behavior or self-mutilation will not be included.
- Women with gestational potential can only be included if they are using reliable contraception.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655030
Contacts
| Contact: Ricardo Toniolo, MD | 55 11 26617928 | ricardo.toniolo@uol.com.br |
Locations
| Brazil | |
| Institute of Psychiatry - HC-FMUSP | |
| Sao Paulo, SP, Brazil, 01060-970 | |
Sponsors and Collaborators
University of Sao Paulo
Investigators
| Principal Investigator: | Beny Lafer, PhD | Bipolar Disorder Research Program, Coordinator, IPq-HC-FMUSP |
More Information
No publications provided
| Responsible Party: | Ricardo Alexandre Toniolo, MD, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01655030 History of Changes |
| Other Study ID Numbers: | CR-BD-RCT |
| Study First Received: | July 29, 2012 |
| Last Updated: | July 31, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013