Depression, BipolarPhase 3APOLLONCT03423680
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
A Phase 3 study testing Abilify 2, 5, 10, 15mg (Tablet) in people with Depression, Bipolar, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Depression, Bipolar
- What is being tested?
- Abilify 2, 5, 10, 15mg (Tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2018to Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seounl National University Hospital
Seoul
Yong Min Ahn, MD PhD
About this study
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
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
- Being tested
- Abilify 2, 5, 10, 15mg (Tablet), Placebo of Abilify 2, 5, 10, 15mg (Tablet)
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Abilify (Tablet) | Experimental | Not described Receives: Drug: Abilify 2, 5, 10, 15mg (Tablet) |
| Placebo of Abilify (Tablet) | Placebo comparator | Not described Receives: Drug: Placebo of Abilify 2, 5, 10, 15mg (Tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (4)
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.
Measured: Week 8
Response rate
Measured: Week 8
Remission rate
Measured: Week 8
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start22 Feb 2018
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, BipolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423680
- Sponsor's protocol ID
- 031-402-00154
- Acronym
- APOLLO
- Status last verified
- Aug 2024
- First submitted
- 31 Jan 2018
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03423680
- Acronym / sponsor ID
- APOLLO / 031-402-00154
- Conditions
- Depression, Bipolar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Abilify (Tablet) |
| 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. | Drug | Placebo of Abilify (Tablet) |
Primary outcome
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.
4 secondary outcomes
Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score
Time frame: Week 8
Response rate
Time frame: Week 8
Remission rate
Time frame: Week 8
Percentage of subjects with Clinical Global Impression-BP version Severity of Illness (Depression) score of 1 or 2
Time frame: Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abilify 2, 5, 10, 15mg (Tablet) in people with Depression, Bipolar, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hoyoung Lee (82-2-3287-9238, hoyounglee@otsuka.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in the Montgomery-Åsberg Depression Rating Scale total score (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.