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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03423680
Other study ID # 031-402-00154
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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