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Risk Factors for AD-Associated Switch to Mania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01503489
First Posted: January 4, 2012
Last Update Posted: January 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eduard Vieta Pascual, Hospital Clinic of Barcelona
  Purpose
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 Intervention
Bipolar Disorder. Drug: Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Eduard Vieta Pascual, Hospital Clinic of Barcelona:

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. [ Time Frame: 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.



Enrollment: 221
Study Start Date: October 2005
Study Completion Date: July 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Bipolar I and II disorder patients.
Criteria

Inclusion Criteria:

  • Bipolar I and II disorder.

Exclusion Criteria:

  • Major medical comorbidities.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503489


Locations
Spain
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.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eduard Vieta Pascual, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01503489     History of Changes
Other Study ID Numbers: SWITCH.
First Submitted: December 29, 2011
First Posted: January 4, 2012
Last Update Posted: January 4, 2012
Last Verified: January 2012

Keywords provided by Eduard Vieta Pascual, Hospital Clinic of Barcelona:
Switch.

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Antidepressive Agents
Serotonin
Norepinephrine
Serotonin Uptake Inhibitors
Antidepressive Agents, Tricyclic
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators