Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder

NCT02046564 | Completed Phase 3 Results

• 2 other identifiers: 031-12-005JapicCTI-142413
• Study Type: interventional
• Target: 412
• Locations: 5 countries
• Sites: 29

Brief Summary

To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination) compared to sertraline monotherapy in patients with major depressive disorders who have responded incompletely to sertraline monotherapy.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

  The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.Summed subscales are combined to compute a total score. Total score ranges from 0 to 60, with higher score indicating worse condition.

  8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Secondary Outcomes (8)

• The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate

  8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

• The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate

  8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

• The Clinical Global Impression - Improvement (CGI-I) Improvement Rate

  6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

• The Mean Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S)

  8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

• The Mean Change From Baseline in the Hamilton Depression Rating Scale 17 (HAM-D17) Total Score

  8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])

Study Arms (2)

ASC-01

EXPERIMENTAL

The dose of 3-12mg/100mg(Aripiprazole/Sertraline Combination)will be orally administered once daily

Drug: ASC-01

Placebo

PLACEBO COMPARATOR

The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily

Drug: Placebo

Interventions

ASC-01 DRUG

ASC-01

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who are either inpatients or outpatients.
• Patients who are able to understand necessary information for giving consent to undergo examinations, observations, and evaluations specified in this clinical protocol, and who are able to give written consent based on a full understanding of the trial.
• Patients who have been given a diagnosis of "Major Depressive Disorder, Single Episode" or "Major Depressive Disorder, Recurrent" according to the DSM-5 and who have a current episode of major depression that has been continuing for at least 8 weeks
• Patients with a HAM-D 17 total score of 18 or more at the Screening Period evaluation

You may not qualify if:

• Female patients of childbearing potential who wish to become pregnant during the trial period or within 4 weeks after completion or discontinuation of the trial
• Pregnant or breast-feeding female patients, or female patients who may be pregnant
• Patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history
• Patients who have had electroconvulsive therapy
• Patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent
• Patients who have a medical history suggesting a risk of developing serious adverse events or symptoms that may hinder efficacy/safety evaluation (eg, symptoms of fibromyalgia, or premenstrual syndrome etc that overlap with depressive symptoms)
• Patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic
• fasting blood glucose level ≥ 126 mg/dL
• hour glucose level in 75-g oral glucose tolerance test (OGTT) ≥ 200 mg/dL
• non-fasting blood glucose level ≥ 200 mg/dL
• HbA1c \[NGSP level\] ≥ 6.5%
• Patients who are undergoing treatment for thyroid disease (except for patients whose disease has been stabilized with drug therapy for 3 months or longer before the time of informed consent)
• Patients who have a history of neuroleptic malignant syndrome or serotonin syndrome
• Patients who have a history of seizure disorder (eg, epilepsy)

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (29)

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Everton Park, Queensland, Australia

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Melbourne, Australia

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Chubu Region, Japan

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Chugoku Region, Japan

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Hokkaido Region, Japan

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Kanto Region, Japan

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Kinki Region, Japan

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Kyushu Region, Japan

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Tohoku Region, Japan

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Ipoh, Malaysia

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Johor Bahru, Malaysia

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Kuala Lumpur, Malaysia

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Kuching, Malaysia

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Busan, South Korea

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Chungcheongnam-do, South Korea

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Deagu, South Korea

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Gangwon-do, South Korea

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Gwangju, South Korea

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Gyeonggi-do, South Korea

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Incheon, South Korea

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Jeollabuk-do, South Korea

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Seoul, South Korea

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Chiayi City, Taiwan

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Kaohsiung City, Taiwan

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Keelung, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co. Ltd.

+81-3-6361-7366

Study Officials

• Hiroaki Ono, Mr

  Otsuka Pharmaceutical Co., Ltd.

  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: January 23, 2014
• First Posted: January 28, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 21, 2018
• Results First Posted: May 21, 2018

Record last verified: 2018-05

Locations

MY (4); JP (7); AU (2); KR (9); TW (7)