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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004144
Receipt No. R000004891
Scientific Title Efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder: a multicenter open-label randomized controlled trial.
Date of disclosure of the study information 2010/09/02
Last modified on 2017/09/07

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Basic information
Public title Efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder: a multicenter open-label randomized controlled trial.
Acronym Efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder: a multicenter, open-label, randomized, controlled trial.
Scientific Title Efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder: a multicenter open-label randomized controlled trial.
Scientific Title:Acronym Efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder: a multicenter, open-label, randomized, controlled trial.
Region
Japan

Condition
Condition Major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of mirtazapine for sleep disturbance and anxiety symptoms compared with selective serotonin reuptake inhibitors in patients with major depressive disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Rate of patients taking benzodiazepines at 6, 12, and 24 weeks
Key secondary outcomes 1) Response rate by Hamilton Depression Rating Scale(HDRS17) 2) Athene Insomnia Scale (AIS)
3) Zung Self-rating Depression Scale (SDS)
4) Incidence rate of activation syndrome
5) Incidence rate of discontinuation symptoms
6) Clinical Global Inventory (CGI)
7) Serum levels of brain-derived neurotrophic factor (BDNF) at baseline, 6, 12, and 24 weeks
8) five year follow-up of patients

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Mirtazapine (15-45 mg/day) will be continued continued for 6 weeks. Follow-up period is 24 weeks.
Interventions/Control_2 Paroxetine (20-40 mg/day) or Paroxetine controlled-release (25-50 mg/day) will be continued continued for 6 weeks. Follow-up period is 24 weeks.
Interventions/Control_3 Sertraline (25-100 mg/day) will be continued continued for 6 weeks. Follow-up period is 24 weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with current major depressive episode
2. Major depessive diorder by DSM-IV-TR
3. Patients with 12 or over in HDRS-17
4. Patients thought to need antidepressant treatments in the judgment of the consulting psychiatrist
5. Patients with 20-75 years of age at study entry
6. Written informed consent by patients
Key exclusion criteria 1. Patients without 20-75 years of age at study entry
2. Patients treated to current major depressive episode with the antidepressants as the trial intervention
3. Allergy against mirtazapine, paroxetine, and sertraline
4. Patients treated with pimozide
5. Patients treating with or discontinued within 14 days with selegiline, monoamine oxidase inhibitors
6. Patients with severe hormone diseases
7. Significant risk of suicide (HDRS-17 suicide score 3 or over)
8. Pregnant women or women, who may be pregnant
9. Breast-feeding women
10. Patients with substance abuse/dependence
11. Patients with alcohol abuse/dependence
12. Patients with dementia, bipolar or psychotic disorders, those with a primary diagnosis of obsessive-compulsive disorder or an eating disorder
13. Patient whom examination doctor judge improper as a trial subject
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL +81-43-226-2148
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tasuku Hashimoto
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL +81-43-226-2148
Homepage URL
Email t-hashimoto@faculty.chiba-u.jp

Sponsor
Institute Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 G22005
Org. issuing International ID_1 IRB committee in Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 旭中央病院 Asahi Hospital(千葉県, Chiba Pref)、千葉医療センター National Hospital Organization Chiba Medical Center(千葉県, Chiba Pref)、藤田病院 Fujita Hospital(千葉県, Chiba Pref)、亀田総合病院 Kameda Medical Center(千葉県, Chiba Pref)、袖ヶ浦さつき台病院 Sodegaura Satsukidai Hospital(千葉県, Chiba Pref)、木更津病院 Kisarazu Hospital(千葉県, Chiba Pref)、木村病院 Kimura Hospital(千葉県, Chiba Pref)、こころの健康クリニック津田沼 Kokoronokenko Tsudanuma Clinic(千葉県, Chiba Pref)、心の風クリニック Kokoronokaze Clinic(千葉県, Chiba Pref)、そが西口クリニック Soganishiguchi Clinic(千葉県, Chiba Pref)、木更津メンタルクリニック Kisarazu Mental Clinic(千葉県, Chiba Pref)、銚子こころクリニック Choshikokoro Clinic(千葉県, Chiba Pref)、

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27777607
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2010 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 02 Day
Last modified on
2017 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004891

Research Plan
Registered date File name
2017/09/07 Hashimoto_et_al-2016-Annals_of_General_Psychiatry.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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