Risk Factors for AD-Associated Switch to Mania
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Bipolar depressed patients 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.
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Bipolar I and II disorder.
Exclusion Criteria:
- Major medical comorbidities.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital Clinic Barcelona | Barcelona | Catalonia | Spain | 08037 |
Sponsors and Collaborators
- Hospital Clinic of Barcelona
Investigators
- Study Director: Marc Valenti, MD, Bipolar Disorders Program, Hospital Clinic Barcelona.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SWITCH.