Recruitment

Recruitment Status
Completed
Estimated Enrollment
400

Inclusion Criteria

Patients who are either inpatients or outpatients.
Patients with a HAM-D 17 total score of 18 or more at the Screening Period evaluation
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 who are either inpatients or outpatients.
Patients with a HAM-D 17 total score of 18 or more at the Screening Period evaluation
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 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.

Exclusion Criteria

Pregnant or breast-feeding female patients, or female patients who may be pregnant
non-fasting blood glucose level ≥ 200 mg/dL
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)
...
Pregnant or breast-feeding female patients, or female patients who may be pregnant
non-fasting blood glucose level ≥ 200 mg/dL
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)
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
2-hour glucose level in 75-g oral glucose tolerance test (OGTT) ≥ 200 mg/dL
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 a history of seizure disorder (eg, epilepsy)
fasting blood glucose level ≥ 126 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 enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent
Patients who have had electroconvulsive therapy

Summary

Conditions
Major Depressive Disorder
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 64 years
Gender
Both males and females

Inclusion Criteria

Patients who are either inpatients or outpatients.
Patients with a HAM-D 17 total score of 18 or more at the Screening Period evaluation
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 who are either inpatients or outpatients.
Patients with a HAM-D 17 total score of 18 or more at the Screening Period evaluation
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 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.

Exclusion Criteria

Pregnant or breast-feeding female patients, or female patients who may be pregnant
non-fasting blood glucose level ≥ 200 mg/dL
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)
...
Pregnant or breast-feeding female patients, or female patients who may be pregnant
non-fasting blood glucose level ≥ 200 mg/dL
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)
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
2-hour glucose level in 75-g oral glucose tolerance test (OGTT) ≥ 200 mg/dL
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 a history of seizure disorder (eg, epilepsy)
fasting blood glucose level ≥ 126 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 enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent
Patients who have had electroconvulsive therapy

Tracking Information

NCT #
NCT02046564
Collaborators
Not Provided
Investigators
Study Director: Hiroaki Ono, Mr Otsuka Pharmaceutical Co., Ltd.
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