A Study in Participants With Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) (VENTU...
Last Updated   April 24, 2024 - 21:04
OVERVIEW
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Gender
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Age
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Phase
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Sites
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Status
Recruiting
SUMMARY
The purpose of this study is to assess the socio-demographic, disease-related and treatment-related characteristics, and the standard of care (SOC) treatment patterns of participants with major depressive disorder (MDD) with anhedonia with inadequate response to their current antidepressant treatments and treated according to the standard of care treatment.
CONDITIONS
- Depressive disorder, major
ELIGIBILITY
Inclusion Criteria:
* Meets the diagnostic criteria for single episode or recurrent major depressive disorder (MDD) without psychotic features, according to either the tenth revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) or the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Is considered to suffer from a moderate or severe depressive syndrome, as defined by a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (>=) 22 at entry
* Is initiating or is planning to initiate a new add-on antidepressant treatment per local prescribing information to treat the current depressive episode. In the context of this observational study, a new add-on antidepressant treatment is considered any new pharmacological or non-pharmacological treatment that is prescribed in addition to the current antidepressant treatment, inclusive of an selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI or SNRI) with the intent to improve a participant's clinical depressive syndrome. Accordingly, any dose escalation of an antidepressant prescribed prior to baseline or the addition of any drug intended to increase the plasma-concentration of an antidepressant prescribed prior to baseline is not considered a new antidepressant treatment; In parallel with the inclusion of participants considered for add-on strategy, in the United States only, a cohort of approximately 50 participants who switch to a new single (monotherapy) pharmacological antidepressant agent of any antidepressant class per local prescribing information to replace the current antidepressant treatment (that is, "monotherapy switch strategy") will be enrolled. The enrollment of participants with switch to monotherapy will be monitored, and sites will be notified by the sponsor once the planned number for the cohort is achieved. Thereafter, only add-on strategy participants will be enrolled
* Must be capable of providing informed consent (for example, able to read and write), based on the opinion of the participating physician. Must sign (or their legally acceptable representative) an informed consent form indicating that he or she understands the purpose of the study and that he or she agrees to have their data collected and analyzed, in accordance with local requirements and the study protocol
* Meets the criterion for inadequate response to a current antidepressant treatment that includes an SSRI or SNRI (monotherapy SSRI, monotherapy SNRI, combination of antidepressants that includes SSRI/SNRI or SSRI/SNRI augmentation), administered at an adequate dose (as defined in the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in the current episode of depression
Exclusion Criteria:
* Has a current or prior diagnosis of a psychotic disorder, MDD with psychotic features, bipolar or related disorders or intellectual disability, according to DSM-5 or ICD-10
* Participants who require an antidepressant (SSRI/SNRI) change (switch to another antidepressant monotherapy), except for a limited number of participants to be recruited in the United States only
* Unstable general medical condition (for example, cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic, or endocrine disorders) in the past 3 months that would compromise participation and normal routine medical care per the physician's clinical judgment
* Has lack of treatment response to the current antidepressant therapy that includes a SSRI/SNRI (that is, no [0%] symptomatic improvement despite adequate dose and duration of the antidepressant treatment) assessed using the MGH ATRQ
* History of dementia or mild cognitive impairment. Physician's clinical judgment should document that participant is capable of complying with observational study requirements and being able to complete the appropriate scales
* Has homicidal ideation/intent or is at imminent risk of suicide per the physician's clinical judgment and/or based on the Columbia Suicide Severity Rating Scale (C-SSRS) corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent)
DETAILS
LOCATIONS
Country (9) | City or Province (44) | Status |
United States | Allentown, PA Lehigh Center for Clinical Research |
RECRUITING
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United States | Atlanta, GA Atlanta Behavioral Research, LLC |
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United States | California City, CA ATP Clinical Research |
RECRUITING
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United States | Chicago, IL University of Chicago |
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United States | Columbia, MO Missouri University Health Care South Providence Psychiatry |
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United States | Fairlawn, OH Signature Research Associates Inc. |
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United States | Farmington, CT University of Connecticut Health Center |
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United States | Marietta, GA Psych Atlanta, P.C. |
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United States | Naperville, IL Baber Research Group |
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United States | Saint Augustine, FL Flagler Hospital and Florida Center for TMS |
RECRUITING
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United States | Sarasota, FL Center for Revitalizing Psychiatry |
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United States | Tampa, FL Interventional Psychiatry of Tampa Bay |
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United States | Worcester, MA Univeristy of Massachusetts |
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Sweden | Gustavsberg Gustavsbergs Vardcentral |
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Sweden | Halmstad Affecta Pskyiatrimottagning |
RECRUITING
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Sweden | Lund ProbarE i Lund AB |
RECRUITING
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Sweden | Skovde ONE LIFETIME Lakarmottagning |
RECRUITING
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Spain | Barcelona, BA Hosp. de La Santa Creu I Sant Pau |
RECRUITING
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Spain | Jerez de la Frontera Hosp. de Jerez de La Frontera |
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Spain | Madrid, MD Csm Fuencarral |
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Spain | Ponferrada Hosp. El Bierzo |
RECRUITING
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Spain | Valencia, VC Hosp. Univ. I Politecni La Fe |
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Spain | Zamora, ZM Hosp. Prov. de Zamora |
RECRUITING
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South Korea | Daegu Kyungpook National University Hospital |
RECRUITING
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South Korea | Goyang, 41 CHA University ilsan Medical Center |
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South Korea | Incheon Gachon University Gil Medical Center |
RECRUITING
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South Korea | Jeju Special, 49 Jeju National University Hospital |
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South Korea | Seoul Gangnam Severance Hospital, Yonsei University Health System |
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South Korea | Seoul Hallym University Kangdong Sacred Heart Hospital |
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South Korea | Seoul Kangbuk Samsung Hospital |
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South Korea | Seoul Samsung Medical Center |
RECRUITING
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Germany | Berlin, BE Praxis Dr. med. Kirsten Hahn |
RECRUITING
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Germany | Mittweida Pharmakologisches Studienzentrum Chemnitz GmbH |
RECRUITING
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Germany | Nuernberg Gemeinschaftspraxis Prof. Steinbach und Dr. Steib |
RECRUITING
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France | Angers CHU Angers - Hôpital Hôtel Dieu |
RECRUITING
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France | Clermont Ferrand CHU Clermont-Ferrand - Hopital Gabriel Montpied |
RECRUITING
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Canada | Ontario, ON Introspect Clinic |
RECRUITING
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Canada | Toronto, ON Jodha Tishon Inc. |
RECRUITING
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Canada | West Vancouver, BC The Medical Arts Health Research Group |
RECRUITING
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Brazil | Sao Bernardo do Campo, SP Centro Integrado Facili |
RECRUITING
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Argentina | Ciudad Autonoma de Buenos Aires, B Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales |
RECRUITING
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Argentina | Ciudad de Mendoza Resolution |
RECRUITING
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Argentina | Cordoba CEN Consultorios Especializados en Neurociencias |
RECRUITING
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Argentina | Cordoba Centro Medico Luquez |
RECRUITING
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