Clinical trial NCT02046564: Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-blind Trial to Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 412
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
  * 2-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)

Primary outcomes:
measure: The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: 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:
measure: The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate
timeFrame: 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])
measure: The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate
timeFrame: 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])
measure: The Clinical Global Impression - Improvement (CGI-I) Improvement Rate
timeFrame: 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])
measure: The Mean Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S)
timeFrame: 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])
measure: The Mean Change From Baseline in the Hamilton Depression Rating Scale 17 (HAM-D17) Total Score
timeFrame: 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])
measure: The Mean Change From Baseline in the Social Adaptation Self-evaluation Scale (SASS) Total Score
timeFrame: 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])
measure: The Mean Change From Baseline in the Apathy Scale (AS) Total Score
timeFrame: 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])
measure: The Mean Change From Baseline in the Self-rating Version of Montgomery-Åsberg Depression Rating Scale (MADRS-S) Total Score
timeFrame: 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])
Other outcomes:
Locations:
city: Everton Park
country: Australia
state: Queensland
city: Melbourne
country: Australia
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: Tohoku Region
country: Japan
city: Busan
country: Korea, Republic of
city: Chungcheongnam-do
country: Korea, Republic of
city: Deagu
country: Korea, Republic of
city: Gangwon-do
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeollabuk-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Ipoh
country: Malaysia
city: Johor Bahru
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuching
country: Malaysia
city: Chiayi
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Keelung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Hiroaki Ono, Mr
role: STUDY_DIRECTOR
References: