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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Aripiprazole (Fixed dose)
Aripiprazole (Titrated dose)
Placebo
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Fixed dose

Titration dose

Placebo

Outcomes

Primary Outcome Measures

Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
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
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)
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).

Full Information

First Posted
April 2, 2009
Last Updated
December 20, 2013
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00876343
Brief Title
Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
Official Title
Placebo-Controlled, Double-Blind, Parallel Group-Comparison Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
586 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fixed dose
Arm Title
2
Arm Type
Experimental
Arm Description
Titration dose
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Aripiprazole (Fixed dose)
Other Intervention Name(s)
Aripiprazole
Intervention Description
administered orally once daily, 3 mg daily, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Aripiprazole (Titrated dose)
Other Intervention Name(s)
Aripiprazole
Intervention Description
administered orally once daily, 3 to 15 mg daily, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo of aripiprazole
Intervention Description
administered orally once daily, 6 weeks
Primary Outcome Measure Information:
Title
Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
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
Time Frame
Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
Secondary Outcome Measure Information:
Title
MADRS Response Rate
Description
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).
Time Frame
Baseline (the end of the SSRI/SNRI treatment period), at completion of administration
Title
Mean Change in Sheehan Disability Scale (SDISS)
Description
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).
Time Frame
Baseline (the end of the SSRI/SNRI treatment period), at completion of administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
OPC-J
Official's Role
Study Director
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Hokkaido Region
Country
Japan
City
Kanto region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Shikoku Region
Country
Japan
City
Tohoku Region
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24965202
Citation
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.
Results Reference
derived
PubMed Identifier
24074484
Citation
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.
Results Reference
derived

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

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