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

NCT03423680 | Recruiting Phase 3

• 1 other identifier: 031-402-00154
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Bipolar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score

  Week 8

• Response rate

  Week 8

• Remission rate

  Week 8

• Percentage of subjects with Clinical Global Impression-BP version Severity of Illness (Depression) score of 1 or 2

  Week 8

Study Arms (2)

Abilify (Tablet)

EXPERIMENTAL

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

Placebo of Abilify (Tablet)

PLACEBO COMPARATOR

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

Interventions

Abilify 2, 5, 10, 15mg (Tablet) DRUG

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.

Abilify (Tablet)

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

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 (Tablet)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seounl National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Tablets

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Hoyoung Lee

CONTACT

82-2-3287-9238; hoyounglee@otsuka.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: February 22, 2018
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)