Clareo Health | Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
The study will be organized as follows:
* Screening Phase
* Single-blind Prospective Treatment Phase
* Single-blind Continuation Phase (Responder) or Double-blind Randomization Phase (non-Responder)
* 30 day Post Treatment Follow-up
Assigned Interventions:
* Escitalopram monotherapy
* Aripiprazole/Escitalopram combination therapy
* Aripiprazole monotherapy
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration
Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period
Participants with a Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline Visit for the Prospective Treatment Phase
You may not be if
Lack of prior treatment with an antidepressant during the current depressive episode
Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode
Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode
Participants with epilepsy or significant history of seizure disorders
Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
Participants who have received electroconvulsive therapy (ECT) in the last 10 years
