Long-Term Administration 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:
NCT00882362
First received: April 2, 2009
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: OPC-14597 (Aripiprazole)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Administration 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:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline(Day 1), Week52 or at discontinuation ] [ Designated as safety issue: No ]

    Change from baseline to Last Observation Carried Forward (LOCF).

    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



Enrollment: 155
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 Drug: OPC-14597 (Aripiprazole)
administered orally once daily, 3 to 15 mg daily, 52 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
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.

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.)
  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: NCT00882362

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

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00882362     History of Changes
Other Study ID Numbers: 031-08-002, JapinCTI-090725
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 August 27, 2014