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Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00882362
Recruitment Status : Completed
First Posted : April 16, 2009
Results First Posted : February 10, 2014
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: OPC-14597 (Aripiprazole) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
Study Start Date : March 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: OPC-14597 (Aripiprazole)
administered orally once daily, 3 to 15 mg daily, 52 weeks




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline(Day 1), Week52 or at discontinuation ]

    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




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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00882362     History of Changes
Other Study ID Numbers: 031-08-002
JapinCTI-090725
First Posted: April 16, 2009    Key Record Dates
Results First Posted: February 10, 2014
Last Update Posted: February 10, 2014
Last Verified: December 2013

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