Major Depression Disorder Clinical Trial
Official title:
Interventional, Open-label, Flexible-dose, Long-term Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment
Status | Completed |
Enrollment | 132 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Main Inclusion Criteria: - • The patient is a man or woman aged =65 yrs - The patient has Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™). - The patient has an inadequate response to at least one adequate antidepressant treatment in the current Major Depressive Episode (MDE). - The patient has had the current MDE for =8 weeks - The patient is currently treated with a protocol specified ADT for at least 6 weeks - The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator. - Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at screening and baseline - Clinical Global Impression - Severity (CGI-S) total score =3 at screening and baseline Main Exclusion Criteria: - • The patient has a clinically significant unstable illness - The patient has newly diagnosed or unstable diabetes - The patient has a Mini Mental State Exam (MMSE) score <24 - The patient has received Transcranial Magnetic Stimulation (TMS) and/or electroconvulsive therapy (ECT) less than 6 months prior to the Screening. - The patient, in the opinion of the investigator or based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at significant risk of suicide Other protocol defined inclusion and exclusion criteria may apply |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Estonia | EE002 | Tallinn | |
Estonia | EE001 | Tartu | |
Estonia | EE004 | Tartu | |
Estonia | EE003 | Voru | |
Finland | FI001 | Helsinki | |
Finland | FI002 | Kuopio | |
Finland | FI003 | Oulu | |
Finland | FI004 | Tampere | |
Germany | DE002 | Berlin | |
Germany | DE008 | Berlin | |
Germany | DE003 | Frankfurt | |
Germany | DE007 | Hannover | |
Germany | DE006 | Mittweida | |
Germany | DE001 | Schwerin | |
Germany | DE005 | Wiesbaden | |
Poland | PL006 | Bialystok | |
Poland | PL003 | Bydgoszcz | |
Poland | PL001 | Chelmno | |
Poland | PL005 | Gdansk | |
Poland | PL004 | Lublin | |
Poland | PL002 | Pruszcz Gdanski | |
United States | US009 | Allentown | Pennsylvania |
United States | US012 | Arcadia | California |
United States | US001 | Memphis | Tennessee |
United States | US004 | Miami | Florida |
United States | US005 | New York | New York |
United States | US008 | New York | New York |
United States | US002 | O'Fallon | Missouri |
United States | US014 | Oklahoma City | Oklahoma |
United States | US007 | Orlando | Florida |
United States | US011 | San Antonio | Texas |
United States | US006 | Smyrna | Georgia |
United States | US003 | Staten Island | New York |
United States | US010 | Toms River | New Jersey |
United States | US013 | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
United States, Estonia, Finland, Germany, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Adverse Events | Week 30 | Yes |
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