A Phase 3 interventional study of Abilify 2, 5, 10, 15mg (Tablet) and Placebo of Abilify 2, 5, 10, 15mg (Tablet) in Depression, Bipolar, sponsored by Korea Otsuka Pharmaceutical Co., Ltd.. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Korea Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 390 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Korea Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 42 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Abilify 2, 5, 10, 15mg (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.
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.
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.
Time frame: Week 8
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.
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
The score ranges from 1 to 7. Higher score indicates more severe depression.
Time frame: Week 8
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for Nov 2025, 93 months after the start.
Of 29 industry-sponsored phase 3 interventional studies under Bipolar Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 49. This study's planned 93 months is above that.
Counting every sponsor, half of 43 studies reached it within 37 months; a quarter within 21 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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