Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients

Anxiety Disorders and Symptoms Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02012504
• Other study ID #: B2012-127
• Status: Recruiting
• Phase: Phase 0
• First received: November 15, 2013
• Last updated: December 10, 2013
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Shanghai Zhongshan Hospital
• Contact: Xiao Huang
• Phone: +862164041990
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adverse Drug Reaction
• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Drug-Related Side Effects and Adverse Reactions

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Evaluate the symptom of depression, anxiety and quality of life in each time between two groups		one year	Yes