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

Information source: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Aripiprazole (Fixed dose) (Drug); Aripiprazole (Titrated dose) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Otsuka Pharmaceutical Co., Ltd.

Official(s) and/or principal investigator(s):
Katsuhisa Saito, Study Director, Affiliation: OPC-J

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.

Clinical Details

Official title: Placebo-Controlled, Double-Blind, Parallel Group-Comparison Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Secondary outcome:

MADRS Response Rate

Mean Change in Sheehan Disability Scale (SDISS)

Eligibility

Minimum age: 20 Years. Maximum age: 74 Years. Gender(s): Both.

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.)

Locations and Contacts

Chubu Region, Japan

Chugoku Region, Japan

Hokkaido Region, Japan

Kanto region, Japan

Kinki Region, Japan

Kyushu Region, Japan

Shikoku Region, Japan

Tohoku Region, Japan

Additional Information

Starting date: March 2009
Last updated: December 20, 2013

Page last updated: August 20, 2015

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