Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients

Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients Who Meet Comorbidity of Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)

The primary objective is to evaluate the improvement of antidepressant monotherapy on depressive and anxiety symptom in Chinese patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for the comorbidity of major depressive disorder (MDD) and generalized anxiety disorder (GAD)

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorders and Symptoms; Adverse Drug Reaction

Detailed Description

To evaluate the improvement of the quality of life of antidepressant monotherapy on Chinese patients who meet DSM-5 criteria for the comorbidity of MDD and GAD. To monitor adverse events (AEs) and serious adverse events (SAEs) of antidepressant monotherapy

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Xiao Huang; Phone Number: +862164041990

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chinese patients who meet DSM-5 criteria for the combidity of MDD and GAD

Description

Inclusion Criteria:

1. First episode outpatients in department of psychiatry, aged 18-65 years
2. Comorbidity of MDD and GAD according to DSM-5 criteria Hamilton Depression score (HAMD) of ≥18 at screening
3. HAMA≥14 at screening
4. Medically stable
5. Provision of written, informed consent.

Exclusion Criteria:

1. Suicide ideation
2. Use antidepressants within at least 14 days before study begin
3. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence)
4. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse within 4 weeks prior to enrolment
5. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension, renal or hepatic dysfunction, cerebrovascular disease ) as judged by the investigator
6. Women in pregnancy or lactation
7. Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment.
8. Medical history with seizure disorder, except for febrile convulsion
9. Participation in another clinical study within 4 weeks (or longer time according to the local requirement)
10. Receive Electroconvulsive therapy (ECT) before study begin

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Western medicine; venlafaxine or escitalopram
Chinese medcine; Shuganjieyu capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the score of HAMD17 (Hamilton Depression Rating Scale) and HAMA (Hamilton Anxiety Rating Scale) of patients in each time between two groups	The efficacy variables is include: Onset rate: proportion of patient with at least 20% reduction in HAMD total score after 1 week Response rate: proportion of patient with at least 50% reduction in HAMD total score Remission rate: remission is defined as HAMD ≤ 7; remission rate is proportion of patients with remission HAMD total score change from baseline to week 6 and to week 24 (LOCF) during the study. HAMA and the Mos36-item Short Form Health Survey (SF-36) score Change from baseline to week6 and to week 24 (LOCF) during the study.	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the symptom of depression, anxiety and quality of life in each time between two groups	one year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Xiao Huang, MD, Fudan University; Principal Investigator: Jian l Ji, MD, Fudan University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Anxiety Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: B2012-127