Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02400346
• Date of registration: 17/03/2015
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
• Scientific 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
• Date of first enrolment: March 2015
• Target sample size: 132
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02400346
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Estonia, Finland, Germany, Poland, United States

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

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



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Major Depression Disorder

Intervention(s)

Drug: ADT

Drug: Adjunct brexpiprazole

Primary Outcome(s)

Number of Patients With Treatment-Emergent Adverse Events [Time Frame: Baseline to 30 weeks]

Secondary ID(s)

2014-003547-35

16160A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02400346