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 RateMean 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
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