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Completed

NCT Number: NCT00876343

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu Region, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Aripiprazole (Fixed dose)

Drug

administered orally once daily, 3 mg daily, 6 weeks

Other names: Aripiprazole

Aripiprazole (Titrated dose)

Drug

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

Other names: Aripiprazole

Placebo

Drug

administered orally once daily, 6 weeks

Other names: Placebo of aripiprazole

Primary outcomes

  1. 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

    • 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 outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Placebo-Controlled, Double-Blind, Parallel Group-Comparison Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 6, 2009
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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