Risk Factors for AD-Associated Switch to Mania

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Bipolar Disorder

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bipolar I and II disorder. Exclusion Criteria: Major medical comorbidities.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bipolar depressed patients<br>Bipolar I or II outpatients, current major depressive episode (HDRS-17 over 20). | Drug: Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.<br>* 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.<br>* Other names: Tricyclics Antidepressants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Switch