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Observation of the efficacy and safety of Sertraline in the treatment of depressive patients comorbid with CHD

Observation of the efficacy and safety of Sertraline in the treatment of depressive patients comorbid with CHD

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-12002609
Enrollment
Unknown
Registered
2012-10-20
Start date
2010-09-20
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depressive patients comorbid with CHD

Interventions

depressive patients comorbid with CHD:zloft treatment

Sponsors

Beijing Anzhen Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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

MeasureTime frame
Hamilton Depression Scale (HAMD-17);

Secondary

MeasureTime frame
Clinical global impression scale (CGI);Activity of Daily Living Scale (ADL);

Countries

China

Contacts

Public ContactJianhua HE
jianhuahe09199@yahoo.com.cn+86 13811918071

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026