Bipolar Disease Type I Clinical Trial
— CHAPSOfficial title:
Biomarkers for Bipolar Disorder: Chaperones and Reticulum Endoplasmatic Stress Response CHAP´s Study
| NCT number | NCT00994630 |
| Other study ID # | CHAPS STUDY |
| Secondary ID | |
| Status | Suspended |
| Phase | N/A |
| First received | October 13, 2009 |
| Last updated | August 15, 2011 |
| Start date | January 2010 |
| Verified date | May 2011 |
| Source | University of Sao Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: National Committee of Ethics in Research |
| Study type | Observational |
The purpose of this study is to determine expression of chaperones proteins from the
endoplasmatic reticulum stress response system in bipolar I patients (manic phase) compared
to healthy controls.
Hypothesis: There is no difference in chaperones proteins expression between bipolar I manic
patients and healthy controls
| Status | Suspended |
| Enrollment | 20 |
| Est. completion date | |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Bipolar Disease type I manic phase - YMRS > 14 - HDRS < 9 Exclusion Criteria: - Use of lithium, divalproate, or carbamazepine in therapeutic levels over the past 30 days |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo | Sao paulo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo |
Brazil,