A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
Recruiting
Phase 3
Interventional Study
Depression, Bipolar
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 390 (estimated)
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd. · Industry
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About This Trial
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…
Trial Locations
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Eligibility 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 …
Contacts