Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    NCT01792128
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SPICS-BIPOLAR for Long Term Follow up

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Österreichische Gesellschaft für Bipolare Erkrankungen Identifier:
First received: February 9, 2013
Last updated: February 12, 2013
Last verified: February 2013

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

Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
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:
  • natural course of recurrent affective disorders is monitored: 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: 600
Study Start Date: May 2000
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community of wiener neustadt and neunkirchen


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 identifier: NCT01792128

Sponsors and Collaborators
Österreichische Gesellschaft für Bipolare Erkrankungen
Study Chair: Christian A. Simhandl, Prof.Dr. Bipolar Zentrum Wiener Neustadt
  More Information

No publications provided by Österreichische Gesellschaft für Bipolare Erkrankungen

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Österreichische Gesellschaft für Bipolare Erkrankungen Identifier: NCT01792128     History of Changes
Other Study ID Numbers: SPICS2010, SPICS2010-2
Study First Received: February 9, 2013
Last Updated: February 12, 2013
Health Authority: Austria: Federal Ministry for Health and Women

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
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders processed this record on March 03, 2015