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Strategic Use of New Generation Antidepressants for Depression (SUN(^_^)D)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109693
First Posted: April 23, 2010
Last Update Posted: October 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center of Neurology and Psychiatry, Japan
Information provided by (Responsible Party):
Toshiaki A. Furukawa, Kyoto University
  Purpose
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.

Condition Intervention Phase
Unipolar Major Depressive Episode Drug: Sertraline Drug: Mirtazapine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strategic Use of New Generation Antidepressants for Depression

Resource links provided by NLM:


Further study details as provided by Toshiaki A. Furukawa, Kyoto University:

Primary Outcome Measures:
  • Observer-rated depression severity (PHQ-9) [ Time Frame: 9 weeks ]
    Personal Health Questionnaire-9 is a 9-item structured interview to measure depression severity. It will be rated by blinded telephone interview.


Secondary Outcome Measures:
  • Self-rated depression severity (BDI-II) [ Time Frame: 9 weeks ]
    Beck Depression Inventory-II is a 21-item self-report of depression severity. It will be filled in by the patients themselves.

  • Global rating of side effects (FIBSER) [ Time Frame: 9 weeks ]
    FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects.


Enrollment: 2011
Study Start Date: December 2010
Study Completion Date: December 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continue sertraline
Continue sertraline at the dosage at 3 weeks
Drug: Sertraline
Sertraline 50 mg/d or 100 mg/d for 6 more weeks
Active Comparator: Augment with mirtazapine
Add mirtazapine to sertraline
Drug: Sertraline
Sertraline 50 mg/d or 100 mg/d for 6 more weeks
Drug: Mirtazapine
Augment with or switch to mirtazapine 15-45 mg/d
Active Comparator: Switch to mirtazapine
Stop sertraline and switch to mirtazapine
Drug: Mirtazapine
Augment with or switch to mirtazapine 15-45 mg/d

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109693


Locations
Japan
Nagoya City University Hospital
Nagoya, Aichi, Japan, 467-8602
Kochi Medical School Hospital
Nangoku, Kochi, Japan, 783-8505
Sponsors and Collaborators
Kyoto University
National Center of Neurology and Psychiatry, Japan
Investigators
Principal Investigator: Toshiaki A Furukawa, MD, PhD Kyoto University Graduate School of Medicine / School of Public Health
Study Director: Tatsuo Akechi, MD, PhD Nagoya City University Graduate School of Medical Sciences
Study Director: Norio Watanabe, MD, PhD National Center of Neurology and Psychiatry, Japan
Study Director: Shinji Shimodera, MD, PhD Kochi University Medical School
Study Director: Mitsuhiko Yamada, MD, PhD National Center of Neurology and Psychiatry, Japan
Study Director: Masatoshi Inagaki, MD, PhD Okayama University Graudate School of Medicine
Study Director: Naohiro Yonemoto, MSc National Center of Neurology and Psychiatry, Japan
Study Director: Kazuhira Miki, MD, PhD Miki Mental Clinic, Yokohama, Japan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Toshiaki A. Furukawa, Professor, Kyoto University
ClinicalTrials.gov Identifier: NCT01109693     History of Changes
Other Study ID Numbers: sun-d
First Submitted: April 21, 2010
First Posted: April 23, 2010
Last Update Posted: October 3, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Depression
Depressive Disorder, Major
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Antidepressive Agents
Sertraline
Mirtazapine
Mianserin
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antidepressive Agents, Tricyclic
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Antidepressive Agents, Second-Generation