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

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ClinicalTrials.gov Identifier: NCT03423680
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Depression, Bipolar Drug: Abilify 2, 5, 10, 15mg (Tablet) Drug: Placebo of Abilify 2, 5, 10, 15mg (Tablet) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Abilify (Tablet) 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 Comparator: Placebo of Abilify (Tablet) Drug: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423680


Contacts
Contact: Hoyoung Lee 82-2-3287-9238 hoyounglee@otsuka.co.kr

Locations
Korea, Republic of
Seounl National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yong Min Ahn, MD PhD         
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03423680     History of Changes
Other Study ID Numbers: 031-402-00154
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs