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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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 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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients aged ≥ 19 and \< 70 years at the time of willing to sign a consent form - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

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.

Locations (1)

Seounl National University Hospital
Seoul, South Korea