Bipolar Cohort Neunkirchen, Final Statement

April 29, 2016 updated by: Österreichische Gesellschaft für Bipolare Erkrankungen

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

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

515

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Lower Austria
      • Wiener Neustadt, Lower Austria, Austria, 2700
        • BIPOLAR Zentrum Wiener Neustadt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community of wiener neustadt and neunkirchen

Description

Inclusion Criteria:

  • bipolar

Exclusion Criteria:

  • all other diagnoses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
bipolar patients
unselected admissions of bipolar patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
patients from the cohort are contacted once a year (1 to 6 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Österreichische Gesellschaft für Bipolare Erkrankungen

Investigators

  • Principal Investigator: Christian A. Simhandl, Bipolar Zentrum WN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocoll2
  • SPICS2010-2 (Other Identifier: Österreichische Gesellschaft für Bipolare Erkrankungen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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