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The effect of lorazepam and mirtazapine on sleep disorder in patients with metastatic cancer

Comparing the effect of lorazepam and mirtazapine on sleep disorder in patients with metastatic cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240824062854N1
Enrollment
140
Registered
2024-10-17
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Sleep disorder in patients with metastatic cancer.

Interventions

Intervention 1: Intervention group: Mirtazapine 15 to 30 mg orally is used on days 1 to 4 after chemotherapy. Intervention 2: Intervention group: Lorazepam 1 to 2 mg is used on days 1 to 4 after chemo

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with various types of cancer undergoing chemotherapy who are suffering from insomnia at the beginning of the study based on the interview and initial examination of the psychiatrist (relevant assistant and professor). Patients should not be suffering from other psychiatric disorders or have previously been involved and treated with the investigated disorders. Patients should not be under the influence of drugs and alcohol. The age range of patients is between 15 and 65 years. Patients must be able to communicate with the doctor during the 6 weeks of the study.

Exclusion criteria

Exclusion criteria: Inability to fill out questionnaires People who score higher than the detection limit according to the HADS questionnaire are excluded from the study. Suffering from chronic physical diseases except cancer Suffering from other psychiatric diagnoses Use of various substances and alcohol during the past month. Previous drug sensitivity to mirtazapine and yalorazepam. Lack of consent of the patient or guardian to participate in the study

Design outcomes

Primary

MeasureTime frame
Improving sleep quality questionnaire scores. Timepoint: Initial interview, three days later and six weeks later. Method of measurement: Petersburg Sleep Questionnaire and HADS.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKiana Kouti

Shahid Beheshti University of Medical Sciences

Kiana.kouti1369@gmail.com+98 21 2235 0177

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026