NCT00994630

Brief Summary

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

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Last Updated

August 16, 2011

Status Verified

May 1, 2011

Enrollment Period

1.6 years

First QC Date

October 13, 2009

Last Update Submit

August 15, 2011

Conditions

Bipolar Disease Type I

Study Arms (1)

BP I patients manic phase

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Bipolar Disease type I manic phase

You may qualify if:

  • Bipolar Disease type I manic phase
  • YMRS \> 14
  • HDRS \< 9

You may not qualify if:

  • Use of lithium, divalproate, or carbamazepine in therapeutic levels over the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dna and Rna analysis

Study Officials

  • Ricardo A Moreno, MD, PhD

    Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Brazil

    PRINCIPAL INVESTIGATOR

  • Marcio G Soeiro de Souza, MD

    Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Brazil

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2011

Last Updated

August 16, 2011

Record last verified: 2011-05

Locations

BR(1)