Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients

This study is currently recruiting participants.
Verified December 2013 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT02012504
First received: November 15, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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)


Condition Phase
Adverse Drug Reaction
Anxiety Disorders and Symptoms
Phase 0

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients Who Meet Comorbidity of Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)

Resource links provided by NLM:


Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • Evaluate the score of HAMD17 (Hamilton Depression Rating Scale) and HAMA (Hamilton Anxiety Rating Scale) of patients in each time between two groups [ Time Frame: one year ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Evaluate the symptom of depression, anxiety and quality of life in each time between two groups [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Western medicine
venlafaxine or escitalopram
Chinese medcine
Shuganjieyu capsule

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02012504

Contacts
Contact: Xiao Huang +862164041990 ext 3012

Locations
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Xiao Huang    +862164041990      
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Principal Investigator: Xiao Huang, MD Fudan University
Principal Investigator: Jian l Ji, MD Fudan University
  More Information

No publications provided

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02012504     History of Changes
Other Study ID Numbers: B2012-127
Study First Received: November 15, 2013
Last Updated: December 10, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Anxiety Disorders
Depressive Disorder
Depressive Disorder, Major
Drug Toxicity
Mental Disorders
Mood Disorders
Poisoning
Substance-Related Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014