APOLLO: A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
Study Details
Study Description
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 |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Mean change in the Montgomery-Åsberg Depression Rating Scale total score [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
- Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score [Week 8]
The score ranges from 1 to 7. Higher score indicates more severe depression.
- 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]
The score ranges from 1 to 7. Higher score indicates more severe depression.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged ≥ 19 and < 70 years at the time of informed consent
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Patients who are able to understand information required for providing a consent
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Patients who have received a mood stabilizer (lithium or valproic acid)
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Patients with bipolar I or II disorder accompanied by major depressive episode
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Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits
Exclusion Criteria:
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Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seounl National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 031-402-00154