NCT01503489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

4.3 years

First QC Date

December 29, 2011

Last Update Submit

November 17, 2021

Conditions

Bipolar Disorder

Keywords

Switch

Outcome Measures

Primary Outcomes (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.

    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.

    8 weeks.

Study Arms (1)

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.

Interventions

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

Also known as: Selective Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitor, Tricyclics Antidepressants
Bipolar depressed patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Bipolar I and II disorder patients.

You may qualify if:

  • Bipolar I and II disorder.

You may not qualify if:

  • Major medical comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Catalonia, 08037, Spain

Location

Related Publications (2)

  • 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.

    PMID: 25682854DERIVED

  • 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.

    PMID: 22401488DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Selective Serotonin Reuptake InhibitorsAntidepressive Agents, Tricyclic

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of DrugsAntidepressive AgentsPsychotropic DrugsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Marc Valenti, MD

    Bipolar Disorders Program, Hospital Clinic Barcelona.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 29, 2011

First Posted

January 4, 2012

Study Start

October 1, 2005

Primary Completion

January 1, 2010

Study Completion

July 1, 2011

Last Updated

November 29, 2021

Record last verified: 2021-11

Locations

ES(1)