Bipolar Cohort Neunkirchen, Final Statement

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: Completed

Administrative data

• NCT number: NCT02760693
• Other study ID #: Protocoll2
• Secondary ID: SPICS2010-2
• Status: Completed
• Phase: N/A
• First received: April 27, 2016
• Last updated: April 29, 2016
• Start date: May 2000
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• 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: Completed
• Enrollment: 515
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• 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, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
Austria	BIPOLAR Zentrum Wiener Neustadt	Wiener Neustadt	Lower Austria

Sponsors (1)

Lead Sponsor	Collaborator
Österreichische Gesellschaft für Bipolare Erkrankungen

Country where clinical trial is conducted

Austria, 

References & Publications (3)

Simhandl C, König B, Amann BL. A prospective 4-year naturalistic follow-up of treatment and outcome of 300 bipolar I and II patients. J Clin Psychiatry. 2014 Mar;75(3):254-62; quiz 263. doi: 10.4088/JCP.13m08601. — View Citation

Simhandl C, Radua J, König B, Amann BL. Prevalence and impact of comorbid alcohol use disorder in bipolar disorder: A prospective follow-up study. Aust N Z J Psychiatry. 2016 Apr;50(4):345-51. doi: 10.1177/0004867415585855. Epub 2015 May 13. — View Citation

Simhandl C, Radua J, König B, Amann BL. The prevalence and effect of life events in 222 bipolar I and II patients: a prospective, naturalistic 4 year follow-up study. J Affect Disord. 2015 Jan 1;170:166-71. doi: 10.1016/j.jad.2014.08.043. Epub 2014 Sep 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapses, hospital admissions, 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