Risk Factors for AD-Associated Switch to Mania

Sponsor
Hospital Clinic of Barcelona (Other)
Overall Status
Completed
CT.gov ID
NCT01503489
Collaborator
(none)
221
1
69
3.2

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
  • Drug: Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.

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

Study Type:
Observational
Actual Enrollment :
221 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Jul 1, 2011

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:
  • Selective Serotonin Reuptake Inhibitors
  • Serotonin-Norepinephrine Reuptake Inhibitor
  • Tricyclics Antidepressants
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Professor Eduard Vieta Pascual, MD, Psychiatrist, PhD, MD, PhD, Hospital Clinic of Barcelona
    ClinicalTrials.gov Identifier:
    NCT01503489
    Other Study ID Numbers:
    • SWITCH.
    First Posted:
    Jan 4, 2012
    Last Update Posted:
    Nov 29, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Professor Eduard Vieta Pascual, MD, Psychiatrist, PhD, MD, PhD, Hospital Clinic of Barcelona
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 29, 2021