Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

NCT ID: NCT00876343

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 586 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-07-31

Brief Summary

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

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Fixed dose

Group Type: EXPERIMENTAL

Aripiprazole (Fixed dose)

Intervention Type: DRUG

administered orally once daily, 3 mg daily, 6 weeks

2

Titration dose

Group Type: EXPERIMENTAL

Aripiprazole (Titrated dose)

Intervention Type: DRUG

administered orally once daily, 3 to 15 mg daily, 6 weeks

3

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

administered orally once daily, 6 weeks

Interventions

Aripiprazole (Fixed dose)

administered orally once daily, 3 mg daily, 6 weeks

Intervention Type: DRUG

Aripiprazole (Titrated dose)

administered orally once daily, 3 to 15 mg daily, 6 weeks

Intervention Type: DRUG

Placebo

administered orally once daily, 6 weeks

Intervention Type: DRUG

Other Intervention Names

Aripiprazole; Aripiprazole; Placebo of aripiprazole

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

4. Patients with a HAM-D17 total score of 18 or more

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 antidpressant 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
• Maximum Eligible Age: 74 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

References

Ozaki N, Otsubo T, Kato M, Higuchi T, Ono H, Kamijima K; ADMIRE Study Group. Efficacy of aripiprazole augmentation in Japanese patients with major depressive disorder: a subgroup analysis and Montgomery-Asberg Depression Rating Scale and Hamilton Rating Scale for Depression item analyses of the Aripiprazole Depression Multicenter Efficacy study. Psychiatry Clin Neurosci. 2015 Jan;69(1):34-42. doi: 10.1111/pcn.12214. Epub 2014 Aug 4.

Reference Type: DERIVED

PMID: 24965202 (View on PubMed)

Kamijima K, Higuchi T, Ishigooka J, Ohmori T, Ozaki N, Kanba S, Kinoshita T, Koyama T; ADMIRE Study Group. Aripiprazole augmentation to antidepressant therapy in Japanese patients with major depressive disorder: a randomized, double-blind, placebo-controlled study (ADMIRE study). J Affect Disord. 2013 Dec;151(3):899-905. doi: 10.1016/j.jad.2013.07.035. Epub 2013 Aug 28.

Reference Type: DERIVED

PMID: 24074484 (View on PubMed)

Other Identifiers

JapicCTI-090724

Identifier Type: -

Identifier Source: secondary_id

031-08-001

Identifier Type: -

Identifier Source: org_study_id