Risk Factors for AD-Associated Switch to Mania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eduard Vieta Pascual, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01503489
First received: December 29, 2011
Last updated: January 3, 2012
Last verified: January 2012
  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 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. ] [ Designated as safety issue: Yes ]

    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hospital Clinic of Barcelona

Additional 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.
Study First Received: December 29, 2011
Last Updated: January 3, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital Clinic of Barcelona:
Switch.

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Antidepressive Agents
Antidepressive Agents, Tricyclic
Norepinephrine
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014