Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
This study has been completed.
Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00882362
First received: April 2, 2009
Last updated: July 12, 2012
Last verified: July 2012
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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:
MedlinePlus related topics:
Depression
Drug Information available for:
Aripiprazole
U.S. FDA Resources
Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- Adverse events [ Time Frame: 1, 2, 3, 4, 6, 8th weeks, thereafter every 4 weeks ] [ Designated as safety issue: Yes ]
| 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:
- Patients who are either inpatients or outpatients
- 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
- 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:
- Female patients of child bearing potential who wish to become pregnant during the treatment period, or within 4 weeks after study completion/discontinuation
- Female patients who are pregnant, possibly pregnant, or breast feeding
- 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
- Patients who have previously received electro-convulsive therapy
- Patients who have participated in clinical studies on medical devices or other drugs within the past month
- 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
- Patients with a history or a complication of diabetes
- Patients with thyroid disease (excluding patients who are stabilized on drug therapy for at least 3 months)
- Patients with a history of serotonin syndrome or psychotropic neuroleptic malignant syndrome
- Patients with a history of seizure disorder (epilepsy etc.)
Contacts and Locations
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 |
| Last Updated: | July 12, 2012 |
| 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 May 19, 2013