- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876343
Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
Placebo-Controlled, Double-Blind, Parallel Group-Comparison Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Chubu Region, Japan
-
Chugoku Region, Japan
-
Hokkaido Region, Japan
-
Kanto region, Japan
-
Kinki Region, Japan
-
Kyushu Region, Japan
-
Shikoku Region, Japan
-
Tohoku Region, Japan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- Patients with a HAM-D17 total score of 18 or more
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 antidpressant 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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3
Placebo
|
administered orally once daily, 6 weeks
Other Names:
|
Experimental: 1
Fixed dose
|
administered orally once daily, 3 mg daily, 6 weeks
Other Names:
|
Experimental: 2
Titration dose
|
administered orally once daily, 3 to 15 mg daily, 6 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 |
Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MADRS Response Rate
Time Frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
|
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).
|
Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
|
Mean Change in Sheehan Disability Scale (SDISS)
Time Frame: Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
|
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). |
Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ozaki N, Otsubo T, Kato M, Higuchi T, Ono H, Kamijima K; ADMIRE Study Group. Efficacy of aripiprazole augmentation in Japanese patients with major depressive disorder: a subgroup analysis and Montgomery-Asberg Depression Rating Scale and Hamilton Rating Scale for Depression item analyses of the Aripiprazole Depression Multicenter Efficacy study. Psychiatry Clin Neurosci. 2015 Jan;69(1):34-42. doi: 10.1111/pcn.12214. Epub 2014 Aug 4.
- Kamijima K, Higuchi T, Ishigooka J, Ohmori T, Ozaki N, Kanba S, Kinoshita T, Koyama T; ADMIRE Study Group. Aripiprazole augmentation to antidepressant therapy in Japanese patients with major depressive disorder: a randomized, double-blind, placebo-controlled study (ADMIRE study). J Affect Disord. 2013 Dec;151(3):899-905. doi: 10.1016/j.jad.2013.07.035. Epub 2013 Aug 28.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- 031-08-001
- JapicCTI-090724
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Aripiprazole (Fixed dose)
-
University Hospital, GhentCompleted
-
University of Western Ontario, CanadaPfizerCompleted
-
International Union Against Tuberculosis and Lung...United States Agency for International Development (USAID)UnknownTuberculosisAlgeria, Bolivia, Colombia, Guinea, Mozambique, Nepal, Peru, Tanzania, Vietnam
-
Maimonides UniversityRecruiting
-
Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...CompletedLeukemia | Leukemia, B-Cell, ChronicUnited States
-
University of UtahStanford UniversityCompletedVenous Thromboembolism | Deep Venous Thrombosis | Pulmonary Embolus | Reconstructive SurgeryUnited States
-
Baylor College of MedicineHarris County Hospital District; The Methodist Hospital Research Institute; Center...RecruitingMultiple MyelomaUnited States
-
University Reproductive AssociatesEMD SeronoTerminatedInfertility | Hypothalamic Amenorrhea | HyperprolactinemiaUnited States
-
John Hunter Children's HospitalSydney Children's Hospitals Network; Royal Children's Hospital; Royal North Shore... and other collaboratorsUnknown
-
The University of Texas Health Science Center,...The Methodist Hospital Research Institute; MedStar National Rehabilitation...RecruitingSpinal Cord InjuriesUnited States