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

Primary Purpose

Depression, Bipolar

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Abilify 2, 5, 10, 15mg (Tablet)
Placebo of Abilify 2, 5, 10, 15mg (Tablet)
Sponsored by
Korea Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Bipolar

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seounl National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Abilify (Tablet)

Placebo of Abilify (Tablet)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Response rate
Remission rate
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.

Full Information

First Posted
January 31, 2018
Last Updated
October 22, 2021
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03423680
Brief Title
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abilify (Tablet)
Arm Type
Experimental
Arm Title
Placebo of Abilify (Tablet)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Abilify 2, 5, 10, 15mg (Tablet)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo of Abilify 2, 5, 10, 15mg (Tablet)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in the Montgomery-Åsberg Depression Rating Scale total score
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score
Description
The score ranges from 1 to 7. Higher score indicates more severe depression.
Time Frame
Week 8
Title
Response rate
Time Frame
Week 8
Title
Remission rate
Time Frame
Week 8
Title
Percentage of subjects with Clinical Global Impression-BP version Severity of Illness (Depression) score of 1 or 2
Description
The score ranges from 1 to 7. Higher score indicates more severe depression.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hoyoung Lee
Phone
82-2-3287-9238
Email
hoyounglee@otsuka.co.kr
Facility Information:
Facility Name
Seounl National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Min Ahn, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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