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NCT Number: NCT03423680

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

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.

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Key information

Conditions

Depression, Bipolar Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seounl National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Yong Min Ahn, MD PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Mean change in the Montgomery-Åsberg Depression Rating Scale total score

    Time frame: Week 8

    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 outcomes

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

    Time frame: Week 8

    The score ranges from 1 to 7. Higher score indicates more severe depression.

  2. Response rate

    Time frame: Week 8

  3. Remission rate

    Time frame: Week 8

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

    Time frame: Week 8

    The score ranges from 1 to 7. Higher score indicates more severe depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Hoyoung Lee

CONTACT

[email protected]

82-2-3287-9238

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Acronym: APOLLO

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2018
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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