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NCT01792128 Clinical Trial

SPICS-BIPOLAR for Long Term Follow up

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01792128
Other study ID # SPICS2010
Secondary ID SPICS2010-2
Status Enrolling by invitation
Phase N/A
First received February 9, 2013
Last updated February 12, 2013
Start date May 2000
Est. completion date December 2014

Study information
Verified date February 2013
Source Österreichische Gesellschaft für Bipolare Erkrankungen
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 600
Est. completion date December 2014
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- bipolar

Exclusion Criteria:

- all other diagnoses

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Österreichische Gesellschaft für Bipolare Erkrankungen

Outcome
Type Measure Description Time frame Safety issue
Primary natural course of recurrent affective disorders is monitored: number of participants with adverse events as a measure of safety and tolerability patients from the cohort are contacted once a year (1 to 6 years) No
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