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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Kyoto University
Sponsor:
Collaborator:
National Center of Neurology and Psychiatry, Japan
Information provided by (Responsible Party):
Toshiaki A. Furukawa, Kyoto University
ClinicalTrials.gov Identifier:
NCT01109693
First received: April 21, 2010
Last updated: May 19, 2013
Last verified: May 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Kyoto University:

Primary Outcome Measures:
  • Observer-rated depression severity (PHQ-9) [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    FIBSER stands for Frequency, Intensity and Burden of Side Effects Rating, which is an observer-rated global rating of side effects.


Estimated Enrollment: 2000
Study Start Date: December 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109693

Contacts
Contact: Toshiaki A Furukawa, MD, PhD +81-75-753-9491 furukawa@kuhp.kyoto-u.ac.jp

Locations
Japan
Nagoya City University Hospital Recruiting
Nagoya, Aichi, Japan, 467-8602
Contact: Tatsuo Akechi, MD, PhD    +81-52-853-8271    takechi@med.nagoya-cu.ac.jp   
Principal Investigator: Akechi Tatsuo, MD, PhD         
Kochi Medical School Hospital Recruiting
Nangoku, Kochi, Japan, 783-8505
Contact: Shinji Shimodera, MD, PhD    +81-88-880-2359    shimodes@kochi-u.ac.jp   
Principal Investigator: Shinji Shimodera, MD, PhD         
Sponsors and Collaborators
Kyoto University
National Center of Neurology and Psychiatry, Japan
Investigators
Principal Investigator: Toshiaki A Furukawa, MD, PhD Nagoya City University Graduate School of Medical Sciences
Study Director: Tatsuo Akechi, MD, PhD Nagoya City University Graduate School of Medical Sciences
Study Director: Norio Watanabe, MD, PhD Nagoya City University Graduate School of Medical Sciences
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 National Center of Neurology and Psychiatry, Japan
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

No publications provided by Kyoto University

Additional 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
Study First Received: April 21, 2010
Last Updated: May 19, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on August 28, 2014