Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

NCT ID: NCT00882362

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-07-31

Brief Summary

To examine the safety and efficacy of long term administration of aripiprazole as an adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor (SSRI) or a selective-norepinephrine reuptake inhibitor (SNRI), in subjects with major depressive disorder.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

OPC-14597 (Aripiprazole)

Intervention Type: DRUG

administered orally once daily, 3 to 15 mg daily, 52 weeks

Interventions

OPC-14597 (Aripiprazole)

administered orally once daily, 3 to 15 mg daily, 52 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients who are either inpatients or outpatients

2. Patients who have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial

3. Patients diagnosed as having either "296.2x Major Depressive Disorder, Single Episode" or "296.3x Major Depressive Disorder, Recurrent" according to DSM-IV-TR, and for whom the current episode of major depressive disorder has been ongoing for more than 8 weeks.

Exclusion Criteria

1. Female patients of child bearing potential who wish to become pregnant during the treatment period, or within 4 weeks after study completion/discontinuation

2. Female patients who are pregnant, possibly pregnant, or breast feeding

3. Patients judged to be unable to tolerate any type of antidepressant treatment (including drugs not being used in the current episode of major depressive disorder), based on treatment history to date

4. Patients who have previously received electro-convulsive therapy

5. Patients who have participated in clinical studies on medical devices or other drugs within the past month

6. Patients at risk of having serious adverse events or developing symptoms that could interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia syndrome overlapping with symptoms of depression), based on previous medical history

7. Patients with a history or a complication of diabetes

8. Patients with thyroid disease (excluding patients who are stabilized on drug therapy for at least 3 months)

9. Patients with a history of serotonin syndrome or psychotropic neuroleptic malignant syndrome

10. Patients with a history of seizure disorder (epilepsy etc.)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katsuhisa Saito

Role: STUDY_DIRECTOR

OPC-J

Locations

Chubu Region, , Japan

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Shikoku Region, , Japan

Tohoku Region, , Japan

Countries

Japan

Other Identifiers

JapinCTI-090725

Identifier Type: -

Identifier Source: secondary_id

031-08-002

Identifier Type: -

Identifier Source: org_study_id