Bipolar Cohort Neunkirchen, Final Statement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Österreichische Gesellschaft für Bipolare Erkrankungen
ClinicalTrials.gov Identifier:
NCT02760693
First received: April 27, 2016
Last updated: April 29, 2016
Last verified: April 2016
  Purpose
monitoring system and data base for long term follow up of various treatment strategies in a naturalistic setting of recurrent affective disorders (unipolar, bipolar) open study design, prospective & retrospective

Condition
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SPICS (Secure Platform for Integrating Clinical Studies) for Recurrent (Bipolar) Affective Disorders for Long Term Follow up Treatment Regiments and Outcome in a Natural Setting

Resource links provided by NLM:


Further study details as provided by Österreichische Gesellschaft für Bipolare Erkrankungen:

Primary Outcome Measures:
  • relapses, hospital admissions, number of participants with adverse events as a measure of safety and tolerability [ Time Frame: patients from the cohort are contacted once a year (1 to 6 years) ] [ Designated as safety issue: No ]

Enrollment: 515
Study Start Date: May 2000
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
bipolar patients
unselected admissions of bipolar patients

Detailed Description:
all hospitalized patients of a defined mixed urban and more rural area were consecutively interviewed at admission and entered into the data base. at discharge they gave written informed consent for further tracking and interviews.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community of wiener neustadt and neunkirchen
Criteria

Inclusion Criteria:

  • bipolar

Exclusion Criteria:

  • all other diagnoses
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02760693

Locations
Austria
BIPOLAR Zentrum Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, 2700
Sponsors and Collaborators
Österreichische Gesellschaft für Bipolare Erkrankungen
Investigators
Principal Investigator: Christian A. Simhandl Bipolar Zentrum WN
  More Information

Publications:
Responsible Party: Österreichische Gesellschaft für Bipolare Erkrankungen
ClinicalTrials.gov Identifier: NCT02760693     History of Changes
Obsolete Identifiers: NCT01792128
Other Study ID Numbers: Protocoll2  SPICS2010-2 
Study First Received: April 27, 2016
Last Updated: April 29, 2016
Health Authority: Austria: Federal Ministry for Health and Women
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Österreichische Gesellschaft für Bipolare Erkrankungen:
bipolar disorder, naturalistic cohort study,
defined catchment area,long term treatment

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2016