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Risk Factors for AD-Associated Switch to Mania

Information source: Hospital Clinic of Barcelona
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder.

Intervention: Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics. (Drug)

Phase: N/A

Status: Completed

Sponsored by: Hospital Clinic of Barcelona

Official(s) and/or principal investigator(s):
Marc Valenti, MD, Study Director, Affiliation: Bipolar Disorders Program, Hospital Clinic Barcelona.

Summary

The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage.

Clinical Details

Official title: Risk for Antidepressant-associated Switch From Depression to Hypomania, Mania, or Mixed Episode During the 8 Weeks After the Introduction of an Antidepressant or After Increasing the Dosage of Baseline Antidepressant.

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Risk for antidepressant-associated switch from depression to hypomania, mania, or mixed episode during the 8 weeks after the introduction of an antidepressant or after increasing the dosage of baseline antidepressant.

Detailed description: Treatment of bipolar depression with antidepressants is strongly debated for the methodologically poor and insufficient data supporting their use and the widely held belief that antidepressants can induce new episodes of abnormal mood elevation or accelerate the rate of cycling. The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage, in a prospective, longitudinal design.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Bipolar I and II disorder.

Exclusion Criteria:

- Major medical comorbidities.

Locations and Contacts

Hospital Clinic Barcelona, Barcelona, Catalonia 08037, Spain
Additional Information

Starting date: October 2005
Last updated: January 3, 2012

Page last updated: August 23, 2015

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