A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression (APOLLO)

Otsuka

Status and phase

Enrolling

Phase 3

Conditions

Depression, Bipolar

Treatments

Drug: Placebo of Abilify 2, 5, 10, 15mg (Tablet)

Drug: Abilify 2, 5, 10, 15mg (Tablet)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03423680

031-402-00154

Details and patient eligibility

About

This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features.

This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.

Enrollment

390 estimated patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged ≥ 19 and < 70 years at the time of informed consent
Patients who are able to understand information required for providing a consent
Patients who have received a mood stabilizer (lithium or valproic acid)
Patients with bipolar I or II disorder accompanied by major depressive episode
Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits

Exclusion criteria

Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features
Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history