Trial · NCT05978219
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia
NCT05978219, Phase 4, Completed, National Institute of Mental Health, Dhaka
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia. Trials, record NCT05978219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05978219
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia
- NCT number
- NCT05978219
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 135 participants, actual
- Lead sponsor
- National Institute of Mental Health, Dhaka
- Conditions
- Major Depressive Disorder With Insomnia
- Interventions
- Mirtazapine Tablets
- First posted
- 2023-08-07
- Last updated
- 2024-04-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in mean Hamilton Depression Rating Scale score | At Day 0, Day 14 and Day 42 | Hamilton Depression Rating Scale is one of the most widely used clinician-administered depression assessment scale. The 17-item version score ranges between 0-53 with higher score indicates worse outcome. |
| Primary | Change from baseline in mean Insomnia Severity Index score | At Day 0, Day 14 and Day 42 | The Insomnia Severity Scale is a 7-item and 5-point Likert self-report questionnaire which is used to assess the nature, severity, and impact of insomnia. The total score can be between 0-35 and higher score indicates worse outcome. |
| Secondary | Frequency and severity of side effects experienced by trial patients as measured by Antidepressant Side-Effect Checklist | Day 14 and Day 42 | This is a self-reporting side-effect checklist developed by Royal College of the Psychiatrist for those taking antidepressants. There are 21 items each mentioning a particular side effect and for each item, the participants rated the severity of the specified symptom on a four-point scale (0 absent; 1 mild; 2 moderate; 3 severe) and specified whether a symptom (if present) was likely to be a side-effect of the antidepressant drug (yes or no). |
| Secondary | Change from baseline in mean World Health Organization Quality of Life score | Day 0 and Day 42 | The WHOQOL-BREF is a 26-item questionnaire in a Likert scale format that assesses individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The 26 items can be answered in a 1-5 Likert scale format; The scale is scored by adding up the score on each item to yield a total score for the instrument. It assesses quality of life in four domains namely physical, psychological, social and environmental. The converted scores for each domain range between 0-100 and a higher score indicates higher quality of life in that domain. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05978219
GET https://conductscience.org/api/trials/v1/NCT05978219/registered