Risk Factors for AD-Associated Switch to Mania

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.

• Registration Number: NCT01503489
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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.

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.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2010-01
• Study Completion: 2011-07
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-04
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-17
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

• Bipolar I and II disorder.

Exclusion Criteria

• Major medical comorbidities.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bipolar depressed patients	Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.	Bipolar I or II outpatients, current major depressive episode (HDRS-17 over 20).

Primary Outcome Measures

Name	Time	Method
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.	8 weeks.	Bipolar I or II outpatients, current major depressive episode (HDRS-17 over 20), were treated with any antidepressant combined with treatment-as-usual, as decided by the treating psychiatrist.; Treatment-emergent affective switch was defined as fully syndromic hypomanic, manic, or mixed episode: YMRS \>12 and an increase of 5 points or more compared to the last assessment for hypomanic/manic features, and YMRS and HDRS-17 \>14 for a mixed episode.; The above-mentioned alterations needed to occur within 8 weeks after introduction of the antidepressant or after increasing the dosage.

Trial Locations

Locations (1)

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Catalonia, Spain