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

Depression, Bipolar Clinical Trial

— APOLLO  

Official title:

A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associated With Bipolar I or II Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03423680
• Other study ID #: 031-402-00154
• Status: Recruiting
• Phase: Phase 3
• Start date: February 22, 2018
• Est. completion date: November 2024

Study information

• Verified date: October 2021
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: Hoyoung Lee
• Phone: 82-2-3287-9238
• Email: hoyounglee[@]otsuka.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

Intervention

Drug:
• Abilify 2, 5, 10, 15mg (Tablet)
Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.
• Placebo of Abilify 2, 5, 10, 15mg (Tablet)
Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.

Locations

Country	Name	City	State
Korea, Republic of	Seounl National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in the Montgomery-Åsberg Depression Rating Scale total score	Mean change in the MADRS total score from baseline to the end of the study(Week 8) The total score ranges from 0 to 60. Higher score indicates more severe depression.	Week 8
Secondary	Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score	The score ranges from 1 to 7. Higher score indicates more severe depression.	Week 8
Secondary	Response rate		Week 8
Secondary	Remission rate		Week 8
Secondary	Percentage of subjects with Clinical Global Impression-BP version Severity of Illness (Depression) score of 1 or 2	The score ranges from 1 to 7. Higher score indicates more severe depression.	Week 8