Biomarkers for Bipolar Disorder: Chaperones and Reticulum... | NCT00994630

Studies
Biomarkers for Bipolar Disorder: Chaperones and Reticulum Endoplasmatic Stress Response CHAP´s Study

NCT00994630

Sponsor

University of Sao Paulo

Status

Suspended

Last Update Posted

Aug 16, 2011Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Bipolar Disease Type I

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

fail to get funding

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Aug 2011Estimated

Completion Date

Not provided

First Submitted Date

Oct 13, 2009

First Submission Date that Met QC Criteria

Oct 13, 2009

First Posted Date

Oct 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2011

Last Update Posted Date

Aug 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Label	Type	Description	Intervention Names
BP I patients manic phase

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Bipolar Disease type I manic phase

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo		São Paulo	São Paulo		Brazil