Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients

NCT02012504 | Unknown DMC

• 1 other identifier: B2012-127
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Adverse Drug Reaction; Anxiety Disorders and Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the symptom of depression, anxiety and quality of life in each time between two groups

  one year

Study Arms (2)

Western medicine

venlafaxine or escitalopram

Chinese medcine

Shuganjieyu capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Suicide ideation
• Use antidepressants within at least 14 days before study begin
• Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence)
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse within 4 weeks prior to enrolment
• 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
• Women in pregnancy or lactation
• Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment.
• Medical history with seizure disorder, except for febrile convulsion
• Participation in another clinical study within 4 weeks (or longer time according to the local requirement)
• Receive Electroconvulsive therapy (ECT) before study begin

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Anxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Xiao Huang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Jian l Ji, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Huang

CONTACT

+862164041990

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: December 16, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

CN (1)