depressive patients comorbid with CHD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible to enroll in this trial, all subjects must meet all of the following criteria: 1. 18-75 years old, male or female; 2. Subject meets ICD-10 diagnostic criteria for CHD and DSM-IV criteria for MDD; 3. Subject (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study; 4. Subject must not receive systematic antidepressants therapy in the past two weeks before baseline; 5. Hamilton Depression Scale (HAMD) total score at baseline >=17 points; 6. Subject must be required either to be admitted to hospital with CHD including acute MI or to have been hospitalized for unstable angina in the past 30 days and to be experiencing a current episode of MDD based on DSM-IV criteria.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria can not be enrolled: 1. Two weeks before enrollment, subject continuously takes antidepressants, psychoactive substances, anxiolytic, monoamine oxidase inhibitors, psychoactive herbal preparations, lithium, carbamazepine, or pimozide, or having electroconvulsive therapy (ECT) treatment; 2. Current use of class I antiarrhythmic medications; 3. Two weeks before enrollment, subject continuously takes reserpine, guanethidine, clonidine, or methyldopa; anticonvulsants or neuroleptics; or regular benzodiazepine; 4. Subject initiation of psychotherapy in the last 3 months before enrollment; 5. The cardiac function of the subject is too weak to communicate with the doctor for 15 minutes, or the expected survival duration is less than 12 weeks due to the bad cardiac function; 6. Uncontrolled hypertension (systolic blood pressure> 180mmHg or diastolic blood pressure> 100mmHg); 7. Assignment for cardiac surgery in the next 12 weeks; 8. Resting heart rate <50 times/min; 9. Subject suffering from schizophrenia, schizoaffective disorder, bipolar disorder, dementia history, MI or unstable angina of nonatherosclerotic etiology (e.g. anemia, cocaine use, and periprocedual); 10. Subject judged to be at high risk for or presence of self-harm, suicide, alcohol or substance abuse/dependence in the last 6 months before enrollment; 11. Known hypersensitivity to sertraline hydrochloride; 12. Pregnant or women of childbearing potential not using adequate or breast-feeding female; 13. Relevant history of severe somatic diseases, such as renal, hepatic, or endocrine disease 14. Subject has persisitent clinically significant laboratory abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale (HAMD-17); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical global impression scale (CGI);Activity of Daily Living Scale (ADL); | — |
Countries
China