Clinical Trials Directory

Trials / Completed

CompletedNCT01503489

Risk Factors for AD-Associated Switch to Mania

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.

Status
Completed
Phase
Study type
Observational
Enrollment
221 (actual)
Sponsor
Hospital Clinic of Barcelona · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSelective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.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.

Timeline

Start date
2005-10-01
Primary completion
2010-01-01
Completion
2011-07-01
First posted
2012-01-04
Last updated
2021-11-29

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01503489. Inclusion in this directory is not an endorsement.