Risk Factors for AD-Associated Switch to Mania
Information source: Hospital Clinic of Barcelona
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder.
Intervention: Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics. (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hospital Clinic of Barcelona Official(s) and/or principal investigator(s): Marc Valenti, MD, Study Director, Affiliation: Bipolar Disorders Program, Hospital Clinic Barcelona.
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.
Clinical Details
Official title: 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
Primary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Bipolar I and II disorder.
Exclusion Criteria:
- Major medical comorbidities.
Locations and Contacts
Hospital Clinic Barcelona, Barcelona, Catalonia 08037, Spain
Additional Information
Starting date: October 2005
Last updated: January 3, 2012
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