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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

Page last updated: August 23, 2015

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