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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000031958
Receipt No. R000036493
Scientific Title A randomised controlled trial of treatment with SSRI or SNRI for patients with functional (psychogenic) dizziness
Date of disclosure of the study information 2018/03/29
Last modified on 2021/06/28

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Basic information
Public title A randomised controlled trial of treatment with SSRI or SNRI for patients with functional (psychogenic) dizziness
Acronym A randomised controlled trial of treatment with SSRI or SNRI for patients with functional (psychogenic) dizziness
Scientific Title A randomised controlled trial of treatment with SSRI or SNRI for patients with functional (psychogenic) dizziness
Scientific Title:Acronym A randomised controlled trial of treatment with SSRI or SNRI for patients with functional (psychogenic) dizziness
Region
Japan

Condition
Condition functional (psychogenic) dizziness
Classification by specialty
Psychosomatic Internal Medicine Psychiatry Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purposes of this study is to evaluate: 1) antidepressant treatment can improve the subjective and objective symptoms ; and 2) evaluate differences in treatment effect depending on the types of antidepressants
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical Global Impression improvement(CGI-I) assessed by Psychosomatic physician at 4 weeks
Key secondary outcomes Symptom of dizziness, the score of Hospital Anxiety and Depression Scale(HADS), Dizziness handicap inventory(DHI) and Visual Symptom Scale-short form(VSS-Sf) at 4 weeks

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment based on Selective Serotonin Reuptake Inhibitors(SSRI: escitalopram 10mg) as the main drug for 4 weeks
Interventions/Control_2 Treatment based on Selective Noradrenaline Reuptake Inhibitors (SNRI: milnacipran 50mg) as the main drug for 4 weeks
Interventions/Control_3 Wait for antidepressant treatment, and 4 weeks later, Treatment based on SSRI (escitalopram 10mg) as the main drug for 4 weeks
Interventions/Control_4 Wait for antidepressant treatment, and 4 weeks later, Treatment based on SNRI (milnacipran 50mg) as the main drug for 4 weeks
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
74 years-old >=
Gender Male and Female
Key inclusion criteria Patients with functional (psychogenic) dizziness.
Key exclusion criteria Subjects are excluded if they express suicidal ideation. Other exclusion criteria are currently undergoing treatment with antidepressants or no understanding ability of this study themselves, or no intention of participation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Hashizume
Organization Department of Psychosomatic Medicine, Toho University School of Medicine
Division name Toho University Omori Medical Center
Zip code 143-8541
Address 6-11-1, Omorinishi, Otaku, Tokyo
TEL 03-3762-4151
Email hashi2@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Kazuaki
Middle name
Last name Hashimoto
Organization Department of Psychosomatic Medicine, Toho University Graduate School of Medicine
Division name Toho University Omori Medical Center
Zip code 143-8541
Address 6-11-1, Omorinishi, Otaku, Tokyo
TEL 03-3762-4151
Homepage URL
Email kazuaki.hashimoto@med.toho-u.ac.jp

Sponsor
Institute Department of Psychosomatic Medicine, Toho University School of Medicine
Institute
Department

Funding Source
Organization None
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 Research ethics committee, Toho University Omori Medical Center
Address 6-11-1, Omorinishi, Otaku, Tokyo
Tel 03-3762-4151
Email hashi2@med.toho-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 29 Day

Related information
URL releasing protocol https://doi.org/10.15064/jjpm.61.4_364
Publication of results Published

Result
URL related to results and publications https://doi.org/10.15064/jjpm.61.4_364
Number of participants that the trial has enrolled 13
Results Thirteen people participated, but 10 people were included in the analysis due to dropouts. As for changes after 4 weeks, CGI and VSS-sf improved in all patients in the escitalopram group, showing a statistically significant decreasing tendency. No significant changes were observed after 4 weeks in the control group and the milnacipran group.
Results date posted
2021 Year 06 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The subjects were 4 males, 6 females, and an average age of 56.3 years. All cases were aware of floating dizziness, and 3 cases were aware of rotatory vertigo, too.
Participant flow Outpatients who met the protocol of this study
Adverse events One case of drowsiness after the start of treatment and one case of anxiety about oral administration. The relationship with the therapeutic drugs is unknown.
Outcome measures Improvement status of clinical findings(CGI, DHI, VSS-sf and HADS)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2018 Year 03 Month 05 Day
Date of IRB
2018 Year 03 Month 05 Day
Anticipated trial start date
2018 Year 03 Month 29 Day
Last follow-up date
2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 29 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036493

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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