Efficacy and safety of clomipramine for post COVID-19 conditio

Phase 1

Recruiting

• Conditions: ong COVID; Long COVID, post COVID-19 condition

• Registration Number: JPRN-jRCTs031230470
• Lead Sponsor: oda Takamasa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-21
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients who meet all of the following selection criteria and who have obtained sufficient understanding and written consent from the research subject about the contents of this research are eligible for this research.
1) Participants must be meet the WHO-defined Long COVID
2) On the C19-YRSm First Assessment (overall health score) on > 2 points more severe than their pre-COVID baseline
3) 18 to 59 years old
4) Participants attending the outpatient clinic of the research facility
5) Participants are competent to consent and consent is obtained in writing

Exclusion Criteria

Any potential subject who meets the following criteria will be excluded from participating in the study.
1) Participant has a history of substance abuse (drug or alchol) or dependence.
2) Participant has contraindications to taking clomipramine
3) There is a change in a regular prescription drug during the period from 2 weeks before the study participation period to the end
4) Pregnant or lactating
5) Not a native Japanese speaker
6) Participant considered by the principal investigator and sub-investigator(s) to be inappropriate for the safe conduct of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome evaluation will be the Safety.

Secondary Outcome Measures

Name	Time	Method
Scores for the following indicators at each time points and the score as measured by the change from baseline to each time points.<br>1) Modified COVID-19 Yorkshire Rehabilitation Screening: C19-YRSm<br>2) MOS Short-Form 36-Item Health Survey: SF-36v2<br>3) Fatigue Severity Scale: FSS<br>4) 30-sec chair stand test: CS-30<br>5) 6-min walk test: 6MWT<br>6) THINC-it (Cognitive Assessment and Measurement)<br>7) Generalized Anxiety Disorder-7: GAD7<br>8) Patient Health Questionnaire: PHQ-9<br>9) Insomnia Severity Index Japanese version: ISI-J<br>10) EuroQol 5 dimensions 5-level: EQ-5D-5L<br>11) Clinical Global Impressions: CGI