Health Condition 1: F339- Major depressive disorder, recurrent, unspecified Health Condition 2: F329- Major depressive disorder, singleepisode, unspecified
Conditions
Interventions
Intervention1: Dosulepin hydrochloride: All study participants will be prescribed with oral Dosulepin hydrochloride 75mg on baseline, at frequency as decided by the investigator
and followed up to period of 8-Weeks. Progress made by the patient will be reviewed every two (2) weeks, and If the response is considered as inadequate, dose escalation will be done based upon the cl
Sponsors
Dr M Suresh Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex in the age group of 18-65 years. 2. Patient willing to participate in the study and sign an informed consent form. 3. Patients with the diagnosis of the Depressive episode (Single episode or recurrent) (by ICD-10 DCR) without psychotic symptoms. 4. Exhibiting treatment non-response (less than 50% reduction in depressive symptoms) after four weeks of treatment with SSRIs, during which the patient has had an adequate dose for at least three weeks. 5. A condition of general good physical health. 6. Patients with no cognitive impairments and having Mini-Mental State Examination (MMSE) scale score of >=24.
Exclusion criteria
Exclusion criteria: 1. Patients with the Depressive episode (by ICD-10 DCR) with psychotic symptoms. 2. Patients who underwent electroconvulsive therapy within 2 months. 3. Pregnant and nursing women. 4. Women with childbearing potential who are not practicing a reliable method of birth control. 5. Patients with comorbid substance abuse or history of organicity. 6. Patients with a history of the Obsessive-compulsive disorder. 7. Patients with a history of major medical or neurological illness. 8. Patients with recent myocardial infarction, any degree of heart block or other cardiac arrhythmias. 9. Patients with the severe liver disease. 10. Suspected inability or unwillingness to comply with study procedures. 11. Known intolerance to any of the ingredients of Dosulepin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean change in severity of depressive symptoms as measured by the 17-point Hamilton Depression Rating Scale (HAM-D), from baseline to Week 8, post-Dosulepin treatment.Timepoint: Baseline (Week 0) Week 2 Week 4 Week 6 Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in sleep quality and insomnia score measured with Insomnia Severity Index, from baseline to Week 8 post-Dosulepin treatment. 2.Mean change in anxiety symptoms score, measured with the Hamilton Anxiety Rating Scale, from baseline to Week 8 post-Dosulepin treatment. 3.Assessment of type and frequency of side effects as measured with Antidepressant Side-Effect Checklist. 4.Assessment of tolerability measured with the type and frequency of adverse events and Serious AEs reported.Timepoint: Baseline (Week 0) Week 2 Week 4 Week 6 Week 8 | — |
Countries
India
Contacts
Public ContactDr M Suresh Kumar
PSYMED Hospital
Outcome results
None listed