- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01503489
Risk Factors for AD-Associated Switch to Mania
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Catalonia
-
Barcelona, Catalonia, Spain, 08037
- Hospital Clínic Barcelona
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Bipolar I and II disorder.
Exclusion Criteria:
- Major medical comorbidities.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Bipolar depressed patients
Bipolar I or II outpatients, current major depressive episode (HDRS-17 over 20).
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
8 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Marc Valenti, MD, Bipolar Disorders Program, Hospital Clinic Barcelona.
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Bipolar and Related Disorders
- Bipolar Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Serotonin Receptor Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Norepinephrine
- Serotonin
- Antidepressive Agents
- Serotonin Uptake Inhibitors
- Antidepressive Agents, Tricyclic
Other Study ID Numbers
- SWITCH.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bipolar Disorder
-
ProgenaBiomeRecruitingBipolar Disorder | Bipolar I Disorder | Bipolar II Disorder | Bipolar Type I Disorder | Bipolar Disorder Mild | Bipolar Disorder Moderate | Bipolar Disorder SevereUnited States
-
Rush University Medical CenterThe Ryan Licht Sang Bipolar FoundationCompletedBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar Disorder I | Bipolar Affective DisorderUnited States
-
University of PittsburghNational Alliance for Research on Schizophrenia and DepressionCompletedBipolar I Disorder | Bipolar II Disorder | Bipolar Disorder NOSUnited States
-
Region StockholmKarolinska InstitutetRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II Disorder | Bipolar Affective Disorder; Remission in | Bipolar Affective Disorder, Currently Depressed, ModerateSweden
-
Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do Sul; Hospital Moinhos de VentoActive, not recruitingBipolar Disorder | Bipolar Depression | Major Depressive Disorder | Bipolar I Disorder | Affective Disorder | Bipolar II DisorderBrazil
-
Medical University of South CarolinaMilken InstituteCompletedBipolar Disorder | Bipolar I Disorder | Bipolar II DisorderUnited States
-
Mayo ClinicCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
-
Joshua RosenblatRecruitingBipolar Disorder | Bipolar Depression | Bipolar I Disorder | Bipolar II DisorderCanada
-
Myriad Genetic Laboratories, Inc.University of MinnesotaCompletedMajor Depressive Disorder, Bipolar I and Bipolar IIUnited States
-
Centre for Addiction and Mental HealthUniversity Health Network, TorontoNot yet recruitingBipolar Disorder | Bipolar Depression | Treatment- Resistant Bipolar Disorder | Type 2 Bipolar DisorderCanada
Clinical Trials on Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.
-
Pamlab, Inc.Baylor Health Care System; Red Oak Psychiatry Associates, PACompletedMajor Depressive DisorderUnited States
-
Duke UniversityNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive Disorder | Anxiety Disorders | Eating Disorders | Depressive DisordersUnited States
-
Ohio State UniversityWithdrawnDementia | Alzheimer Disease | Mild Cognitive ImpairmentUnited States
-
The Cleveland ClinicCompletedBipolar Disorder | Major DepressionUnited States
-
Second Affiliated Hospital, School of Medicine,...UnknownTherapeutic Mechanism of Antidepressants for Refractory FDChina
-
University of WashingtonPatient-Centered Outcomes Research Institute; Boston University; Washington State... and other collaboratorsActive, not recruiting
-
Shanghai Mental Health CenterRenJi Hospital; Huashan Hospital; Shanghai 10th People's Hospital; Shanghai Jiao... and other collaboratorsUnknownMajor Depressive DisorderChina
-
University GhentUniversity Hospital, GhentCompletedDepressive Disorder, Major | Treatment Resistant Depression | MelancholiaBelgium
-
VA Office of Research and DevelopmentNot yet recruitingTraumatic Brain Injury (TBI)United States
-
Eli Lilly and CompanyBoehringer IngelheimCompletedDiabetes Mellitus, Type 2India, Turkey, United States, Puerto Rico, Taiwan, Korea, Republic of, Russian Federation