Strategic Use of New Generation Antidepressants for Depression
Information source: Kyoto University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unipolar Major Depressive Episode
Intervention: Sertraline (Drug); Mirtazapine (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Kyoto University Official(s) and/or principal investigator(s): Toshiaki A Furukawa, MD, PhD, Principal Investigator, Affiliation: Kyoto University Graduate School of Medicine / School of Public Health Tatsuo Akechi, MD, PhD, Study Director, Affiliation: Nagoya City University Graduate School of Medical Sciences Norio Watanabe, MD, PhD, Study Director, Affiliation: National Center of Neurology and Psychiatry, Japan Shinji Shimodera, MD, PhD, Study Director, Affiliation: Kochi University Medical School Mitsuhiko Yamada, MD, PhD, Study Director, Affiliation: National Center of Neurology and Psychiatry, Japan Masatoshi Inagaki, MD, PhD, Study Director, Affiliation: Okayama University Graudate School of Medicine Naohiro Yonemoto, MSc, Study Director, Affiliation: National Center of Neurology and Psychiatry, Japan Kazuhira Miki, MD, PhD, Study Director, Affiliation: Miki Mental Clinic, Yokohama, Japan
Summary
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.
Clinical Details
Official title: Strategic Use of New Generation Antidepressants for Depression
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Observer-rated depression severity (PHQ-9)
Secondary outcome: Self-rated depression severity (BDI-II)Global rating of side effects (FIBSER)
Eligibility
Minimum age: 25 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Nagoya City University Hospital, Nagoya, Aichi 467-8602, Japan
Kochi Medical School Hospital, Nangoku, Kochi 783-8505, Japan
Additional Information
Starting date: December 2010
Last updated: March 30, 2015
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