Efficacy and safety of clomipramine for post COVID-19 condition

JRCT ID: jRCTs031230470

Registered date:21/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Long COVID
• Date of first enrollment: 21/11/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Take the clomipramine tablet orally once daily.
Clinical Global Impressions Scale (CGI) will be performed weekly after the start of administration. If well tolerated, clomipramine dose will be increased by 10 mg (1 tablet) for subjects who do not show improvement among 4 weeks. Max 50mg. Take for 8 weeks from the start.

Outcome(s)

• Primary Outcome: The primary outcome evaluation will be the Safety.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 60age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Noda Takamasa
• Source(s) of Monetary Support: Psychiatric and Neurological Disorder Research and Development Expenses_Establishment of R&amp;D Infrastructure for Psychiatric Treatment Methods Based on Biomarkers
• Secondary ID(s): Nil known