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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01503489

Enrollment

221

Registered

2012-01-04

Start date

2005-10-31

Completion date

2011-07-31

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Switch

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.

Interventions

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Bipolar I and II disorder.

Exclusion criteria

* Major medical comorbidities.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026