UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004144 |
|---|---|
| Receipt number | 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 09:17:03 |
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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
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
t-hashimoto@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
