UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000036493