Ravindran Research Lab - Biomarkers

Ravindran Research Lab

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Clinical Trials

Brexpiprazole (Study Closed)

Diagnosis: MDD

Study: Brexpiprazole as an adjunctive therapy to antidepressants in MDD (8 week open-label)

This is a phase 4, multicenter study designed to assess the effects of flexibly dosed brexpiprazole as and adjunctive therapy to antidepressant therapy in Major Depressive Disorder .

Inclusion:

18-65 years old
Primary diagnosis of MDD and in a current non-psychotic Major Depressive Episode (MDE) according to DSM-5 criteria, have been outpatients for at least 4 weeks and deemed by investigator to have an inadequate response to 1 or 2 ADTs in their current MDE, including current ADT
Patient Health Questionnaire 9-item scale (PHQ-9) score greater than 14 at screening and baseline visits

Exclusion:

Females who are breastfeeding and/or are pregnant at the time of enrollment, or who plan to become pregnant during the trial
Currently or previously treated with brexpiprazole
Concurrent DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, PTSD, dementia, eating disorder, borderline personality disorder, antisocial personality disorder, suicidality, or are deemed by the investigator to present a serious risk of suicide
Receiving psychotherapy at baseline that is not expected to continue throughout the trial
Have received neurostimulation as used for treatment resistant depression
Current, prior, or planned (during trial) use of ketamine and/or esketamine for treatment of depression
Current use of oral, immediate release intramuscular, or long-acting injectable (LAI) antipsychotics at baseline and within 7 day prior to trial participation (one treatment cycle for LAIs)
Currently participating in another clinical trial
Any patient without baseline blood glucose and CBC including white blood cell counts
A medical condition that would expose them to undue risk or interfere with trial endpoints
Contraindications, warnings, and precautions of the Canadian product monograph