A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Depressive Disorder, Major

Treatments: Drug: Escitalopram

Study type: Interventional

Funder types: Industry

Identifiers

NCT01870843

ESCITALDEP4005 (Other Identifier)

CR100826

ESC-C-11-CN-002-V04 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of escitalopram on quality of life and social functionality in patients with major depressive disorder with anxiety symptom.

Full description

This is an open-label (all people know the identity of the intervention), multi-center, prospective (a study in which the participants are identified and then followed forward in time for the outcome of the study), single-arm (all participants receiving one intervention) study. Approximately 260 participants will be enrolled in this study. This study consists of two phases: screening phase and treatment phase. In the treatment phase, participants will receive escitalopram for 8 weeks: escitalopram 10 mg per day for 1 week and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The total study duration will be approximately 2 years.

Enrollment: 261 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of major depressive disorder according to the American Psychiatric Association's Diagnostic and Statistical Manual-IV, Text Revision (DSM-IV-TR) diagnostic criteria
• Minimum scores of 9 on Sheehan Disability Scale
• Minimum scores of 14 on Hamilton Anxiety Scale

Exclusion criteria

• History of primary or comorbid diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder, or dementia
• Presence of unstable serious illness and/or has a clinically significant renal or hepatic impairment, seizure disorders or any other disease which may be detrimental to the participant or the study
• Participant who have continuously taken psychoactive substances, antidepressants, anxiolytics, Monoamine oxidase inhibitors, psychoactive herbal remedies, lithium, electroconvulsive therapy, carbamazepine in the past 2 weeks before the baseline visit
• Diagnosis of major depressive disorder who currently require treatment systematically within past 2 months from baseline
• Receiving pharmacological treatment, which is disallowed in the current approved Chinese summary of product characteristics for escitalopram

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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261 participants in 1 patient group

Escitalopram

Experimental group

Description:

Participants will receive escitalopram 10 mg per day for 1 week and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.

Treatment:

Drug: Escitalopram