UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031958 |
|---|---|
| Receipt number | 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 20:34:48 |
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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
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
kazuaki.hashimoto@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Psychosomatic Medicine, Toho University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036493
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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