NCT00876343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
586

participants targeted

Target at P50-P75 for phase_3 major-depressive-disorder

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_3 major-depressive-disorder

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 10, 2014

Completed
Last Updated

February 10, 2014

Status Verified

December 1, 2013

Enrollment Period

3.3 years

First QC Date

April 2, 2009

Results QC Date

December 20, 2013

Last Update Submit

December 20, 2013

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline (the end of the SSRI/SNRI treatment period), at completion of administration

Secondary Outcomes (2)

  • MADRS Response Rate

    Baseline (the end of the SSRI/SNRI treatment period), at completion of administration

  • Mean Change in Sheehan Disability Scale (SDISS)

    Baseline (the end of the SSRI/SNRI treatment period), at completion of administration

Study Arms (3)

1

EXPERIMENTAL

Fixed dose

Drug: Aripiprazole (Fixed dose)

2

EXPERIMENTAL

Titration dose

Drug: Aripiprazole (Titrated dose)

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Aripiprazole (Fixed dose)DRUG

administered orally once daily, 3 mg daily, 6 weeks

Also known as: Aripiprazole
1
Aripiprazole (Titrated dose)DRUG

administered orally once daily, 3 to 15 mg daily, 6 weeks

Also known as: Aripiprazole
2
PlaceboDRUG

administered orally once daily, 6 weeks

Also known as: Placebo of aripiprazole
3

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

Related Publications (2)

  • 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.

    PMID: 24965202DERIVED

  • 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.

    PMID: 24074484DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Director of Clinical Research and Development
Organization
Otsuka Pharmaceutical Co., Ld.
+81-3-6361-7366

Study Officials

  • Katsuhisa Saito

    OPC-J

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 6, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 10, 2014

Results First Posted

February 10, 2014

Record last verified: 2013-12

Locations

JP(8)