Unipolar Major Depressive Episode Clinical Trial
— SUN(^_^)DOfficial title:
Strategic Use of New Generation Antidepressants for Depression
| Verified date | September 2016 |
| Source | Kyoto University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.
| Status | Completed |
| Enrollment | 2011 |
| Est. completion date | December 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 25 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - non-psychotic unipolar major depressive episode (Diagnostic and Statistical Manual, Fourth Edition [DSM-IV]) in the preceding month - age 25-75 - starting treatment with sertraline clinically indicated - tolerability to sertraline 25 mg/d ascertained - can understand and sign informed consent form - can be contacted by telephone for symptom severity and adverse events Exclusion Criteria: - have received antidepressants, mood stabilizers, antipsychotics, psychostimulants, electroconvulsive therapy (ECT) or depression-specific psychotherapies in the preceding month - history of schizophrenia, schizoaffective disorder or bipolar disorder - current dementia, borderline personality disorder, eating disorder or substance dependence - physical disease interfering with sertraline or mirtazapine treatment - allergy to sertraline or mirtazapine - terminal physical illness - currently pregnant or breast-feeding - high risk of imminent suicide - requiring compulsory admission - expected to change doctors within 6 months - cohabiting relatives of research staff - cannot understand Japanese |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Nagoya City University Hospital | Nagoya | Aichi |
| Japan | Kochi Medical School Hospital | Nangoku | Kochi |
| Lead Sponsor | Collaborator |
|---|---|
| Kyoto University | National Center of Neurology and Psychiatry, Japan |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Observer-rated depression severity (PHQ-9) | Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview. | 9 weeks | No |
| Secondary | Self-rated depression severity (BDI-II) | Beck Depression Inventory-II is a 21-item self-report of depression severity. It will be filled in by the patients themselves. | 9 weeks | No |
| Secondary | Global rating of side effects (FIBSER) | FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects. | 9 weeks | Yes |