Clinical trial NCT02012504: Antidepressant Monotherapy on Depressive and Anxiety Symptom in Chinese Patients
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adverse Drug Reaction
Anxiety Disorders and Symptoms
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese patients who meet DSM-5 criteria for the combidity of MDD and GAD

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)

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 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

Primary outcomes:
measure: Evaluate the score of HAMD17 (Hamilton Depression Rating Scale) and HAMA (Hamilton Anxiety Rating Scale) of patients in each time between two groups
timeFrame: one year
Secondary outcomes:
measure: Evaluate the symptom of depression, anxiety and quality of life in each time between two groups
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xiao Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Jian l Ji, MD
role: PRINCIPAL_INVESTIGATOR
References: