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Bipolar Cohort Neunkirchen, Final Statement

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ClinicalTrials.gov Identifier: NCT02760693
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Österreichische Gesellschaft für Bipolare Erkrankungen

Brief Summary:
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 or disease
Bipolar Disorder

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.

Study Type : Observational
Actual Enrollment : 515 participants
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
Study Start Date : May 2000
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Group/Cohort
bipolar patients
unselected admissions of bipolar patients



Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Other 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 ( Other Identifier: Österreichische Gesellschaft für Bipolare Erkrankungen )
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
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