Efficacy of low dose amitriptyline vs. cognitive behavioural therapy for chronic insomnia and medical comorbidity: a randomized controlled non inferiority trial.

Status

Not yet recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518320-71-00

Acronym

MP-2019-001

Enrollment

190

Registered

2024-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Brief summary

The mean subjective insomnia severity score, measured by the insomnia severity index (ISI) at 12 weeks

Detailed description

Sleep quality quantified by sleep efficiency (by sleep diary), Daytime functioning and symptoms (fatigue, emotional complaints, physical functioning, impairment of functioning)., Adverse events and treatment evaluation (side effects, withdrawal symptoms, and adherence)

Interventions

DRUGAmitriptyline HCl CF 10 mg

DRUGfilmomhulde tabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The mean subjective insomnia severity score, measured by the insomnia severity index (ISI) at 12 weeks	—

Secondary

Measure	Time frame
Sleep quality quantified by sleep efficiency (by sleep diary), Daytime functioning and symptoms (fatigue, emotional complaints, physical functioning, impairment of functioning)., Adverse events and treatment evaluation (side effects, withdrawal symptoms, and adherence)	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026