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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00876343
First received: April 2, 2009
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Aripiprazole (Fixed dose)
Drug: Aripiprazole (Titrated dose)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-Controlled, Double-Blind, Parallel Group-Comparison Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration ] [ Designated as safety issue: No ]

    The change in MADRS total score from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period by covariance analysis, and compared the aripiprazole variable dose group with the placebo group as well as the aripiprazole fixed dose group with the placebo group.

    Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

    The questionnaire includes questions on the following symptoms

    1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts



Secondary Outcome Measures:
  • MADRS Response Rate [ Time Frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration ] [ Designated as safety issue: No ]
    The percentage of subjects with a decrease in MADRS total score of 50% or more, from the end of the SSRI/SNRI treatment period to the end of the placebo-controlled, double-blind treatment period (or withdrawal).

  • Mean Change in Sheehan Disability Scale (SDISS) [ Time Frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration ] [ Designated as safety issue: No ]

    The endpoint evaluated the change in SDISS from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period.

    The patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).



Enrollment: 586
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fixed dose
Drug: Aripiprazole (Fixed dose)
administered orally once daily, 3 mg daily, 6 weeks
Other Name: Aripiprazole
Experimental: 2
Titration dose
Drug: Aripiprazole (Titrated dose)
administered orally once daily, 3 to 15 mg daily, 6 weeks
Other Name: Aripiprazole
Placebo Comparator: 3
Placebo
Drug: Placebo
administered orally once daily, 6 weeks
Other Name: Placebo of aripiprazole

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876343

Locations
Japan
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Shikoku Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito OPC-J
  More Information

No publications provided by Otsuka Pharmaceutical Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00876343     History of Changes
Other Study ID Numbers: 031-08-001, JapicCTI-090724
Study First Received: April 2, 2009
Results First Received: December 20, 2013
Last Updated: December 20, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 23, 2014