NCT01664884

Brief Summary

The aim of this study is to explore the levels of internalized stigma in a sample of young patients with bipolar disorder or schizophrenia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

August 10, 2012

Last Update Submit

August 15, 2012

Conditions

Stigma

Keywords

INTERNALIZED STIGMAINSIGHTSOCIAL ADEQUACYBIPOLAR DISORDERSCHIZOPHRENIA

Study Arms (2)

Bipolar Disorder Patients

Bipolar Disorder Patients, with age between 18 to 40 years old, at euthymic phase.

Schizophrenia Patients

Schizophrenia Patients, with age between 18 to 40 years old, with minimum or none positive symptoms.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The group will consist of patients from the Institute of Psychiatry, Hospital das Clinicas, Faculty of Medicine, University of São Paulo (HCFMUSP) diagnosed by DSM-IV-TR bipolar disorder (in remission) or schizophrenia (absence of positive symptoms).

You may qualify if:

  • Diagnosis of bipolar disorder and schizophrenia according to DSM-IV-TR, presenting in euthymia (bipolar disorder) or without positive symptoms (schizophrenia), based on clinical assessment and confirmed by structured clinical interview SCID-P
  • Age between 18 and 40 years
  • Literate and able to understand the tasks required.
  • Residents of Greater Sao Paulo.
  • Patients and / or legal representatives must understand the nature of the study and sign an informed consent.

You may not qualify if:

  • Patients with Schizoaffective Disorder or Mental Retardation.
  • Unstable serious diseases including kidney disease, gastroenterology, respiratory, cardiovascular, endocrine, neurological, immunological or haematological.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROGRUDA-Institute of Psychiatry- HCFMUSP

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Social StigmaBipolar DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Ricardo Alberto Moreno, MD PhD

    University of Sao Paulo

    STUDY DIRECTOR

Central Study Contacts

Luis Felipe Oliveira Costa, M.D.

CONTACT

+551198053654luis@costa.med.br

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ricardo Alberto Moreno

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations

BR(1)