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Risk Factors for AD-Associated Switch to Mania

NCT ID: NCT01503489

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bipolar Disorder

Keywords

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Switch

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bipolar depressed patients

Bipolar I or II outpatients, current major depressive episode (HDRS-17 over 20).

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Selective Serotonin Reuptake Inhibitors Serotonin-Norepinephrine Reuptake Inhibitor Tricyclics Antidepressants

Eligibility Criteria

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Inclusion Criteria

* Bipolar I and II disorder.

Exclusion Criteria

* Major medical comorbidities.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Professor Eduard Vieta Pascual, MD, Psychiatrist, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc Valenti, MD

Role: STUDY_DIRECTOR

Bipolar Disorders Program, Hospital Clinic Barcelona.

Locations

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Hospital Clinic Barcelona

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

References

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Valenti M, Pacchiarotti I, Undurraga J, Bonnin CM, Popovic D, Goikolea JM, Torrent C, Hidalgo-Mazzei D, Colom F, Vieta E. Risk factors for rapid cycling in bipolar disorder. Bipolar Disord. 2015 Aug;17(5):549-59. doi: 10.1111/bdi.12288. Epub 2015 Feb 12.

Reference Type DERIVED
PMID: 25682854 (View on PubMed)

Valenti M, Pacchiarotti I, Bonnin CM, Rosa AR, Popovic D, Nivoli AM, Goikolea JM, Murru A, Undurraga J, Colom F, Vieta E. Risk factors for antidepressant-related switch to mania. J Clin Psychiatry. 2012 Feb;73(2):e271-6. doi: 10.4088/JCP.11m07166.

Reference Type DERIVED
PMID: 22401488 (View on PubMed)

Other Identifiers

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SWITCH.

Identifier Type: -

Identifier Source: org_study_id