DepressionPhase 4NCT05599126
A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems
A Phase 4 study testing Mianserin and Lorazepam in people with Depression, run by Zhenghui YI at 1 site in China.
Trial summary
Patients with depression with sleep problems have functional abnormalities of 5-HT and NE neurotransmitters, and the NaSSA class antidepressant mianserin has an ameliorative effect on sleep problems along with antidepressant. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Mianserin and Lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meeting the diagnostic criteria for major depressive disorder (DSM-5) with a HAMD-17 score ≥ 17 and a HAMA score ≥ 14.
- Having complaints of sleep problems or PSQI scores >7.
- Han Chinese, age 18-60 years old, junior high school education or above.
- No previous manic episodes or manifestations of mild manic episodes.
- Not taking antidepressants and sedative-hypnotic drugs in the last 2 weeks, or a 7-day cleansing period for those taking drugs.
- No use of convulsion-free electroconvulsive therapy (MECT) within 8 weeks
- Those who voluntarily participated in the study with the patient's informed consent.
Who cannot join
- DSM-5 organic mood disorders; psychiatric disorders associated with somatic diseases; psychiatric disorders due to psychoactive substances.
- Those with contraindications to escitalopram, mianserin, lorazepam medications.
- family history of psychiatric or other somatic disorders.
- Those with excessive psychiatric symptoms unable to complete the interview or unable to understand the content of the scale
- Pregnant and lactating females.
- Those who cannot cooperate with the experimental procedure and cannot cooperate effectively.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Zhenghui Yi, M.D, 18017311007, yizhenghui1971@163.com
About this study
Official title: A Multicenter Open Study of the Efficacy of Mianserin in Combination With SSRIs in Patients With Depression With Sleep Problems
Patients with depression with sleep problems have functional abnormalities of 5-HT and NE neurotransmitters, and the NaSSA class antidepressant mianserin has an ameliorative effect on sleep problems along with antidepressant. However, whether mianserin can improve cognitive function in patients still needs to be explored. The benzodiazepine lorazepam can play a central inhibitory role and has good therapeutic effect on insomnia. The mechanism of action of mianserin and lorazepam is different, and there are few comparative studies related to the combination of the two with SSRI drugs for the treatment of depressed patients with sleep problems, and it is unclear whether there are differences in their efficacy and safety. Therefore, to address the above scientific questions, this study was designed to include 100 patients aged 18-60 years with depression with sleep problems, randomly divided into two groups and treated with mianserin + escitalopram or lorazepam + escitalopram, respectively, and followed up for 8 weeks to assess depression and anxiety symptoms, sleep, cognitive function and drug safety. To compare the efficacy and safety of the two regimens in depressed patients with sleep problems and to provide a scientific basis for clinical intervention in depressed patients with sleep problems.
- Conditions
- Depression
- Being tested
- Mianserin, Lorazepam
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MianserinDrug
Subjects were required to take mianserin regularly during the study period, with the effective dose being taken orally once a night before bedtime.
LorazepamDrug
Subjects were required to take lorazepam regularly during the study period, with the effective dose being taken orally once a night before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Mianserin with escitalopram | Experimental | Not described Receives: Drug: Mianserin |
| Lorazepam with escitalopram | Active comparator | Not described Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index,PSQI
30% reduction in the PSQI scale.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jul 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenghui YI
- Sponsor type
- University, hospital or other
- Collaborators
- Renhe Tang Pharmaceutical Co., Nantong Mental Health Centre (Nantong Fourth People's Hospital), Guangzhou Mental Hospital
- Responsible party
- Sponsor-investigator, Zhenghui YI, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599126
- Sponsor's protocol ID
- 2021-TX-002
- Status last verified
- Jun 2024
- First submitted
- 26 Oct 2022
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open Study of the Efficacy of Mianserin in Combination With SSRIs in Patients With Depression With Sleep Problems
- ClinicalTrials.gov ID
- NCT05599126
- Acronym / sponsor ID
- 2021-TX-002
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhenghui YIUniversity, hospital or other
- Collaborators
- Renhe Tang Pharmaceutical Co., Nantong Mental Health Centre (Nantong Fourth People's Hospital), Guangzhou Mental Hospital
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with depression with sleep problems have functional abnormalities of 5-HT and NE neurotransmitters, and the NaSSA class antidepressant mianserin has an ameliorative effect on sleep problems along with antidepressant. However, whether mianserin can improve cognitive function in patients still needs to be explored. The benzodiazepine lorazepam can play a central inhibitory role and has good therapeutic effect on insomnia. The mechanism of action of mianserin and lorazepam is different, and there are few comparative studies related to the combination of the two with SSRI drugs for the treatment of depressed patients with sleep problems, and it is unclear whether there are differences in their efficacy and safety. Therefore, to address the above scientific questions, this study was designed to include 100 patients aged 18-60 years with depression with sleep problems, randomly divided into two groups and treated with mianserin + escitalopram or lorazepam + escitalopram, respectively, and followed up for 8 weeks to assess depression and anxiety symptoms, sleep, cognitive function and drug safety. To compare the efficacy and safety of the two regimens in depressed patients with sleep problems and to provide a scientific basis for clinical intervention in depressed patients with sleep problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mianserin with escitalopram | Experimental | Drug: Mianserin |
| Lorazepam with escitalopram | Active comparator | Drug: Lorazepam |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meeting the diagnostic criteria for major depressive disorder (DSM-5) with a HAMD-17 score ≥ 17 and a HAMA score ≥ 14.
- Having complaints of sleep problems or PSQI scores >7.
- Han Chinese, age 18-60 years old, junior high school education or above.
- No previous manic episodes or manifestations of mild manic episodes.
- Not taking antidepressants and sedative-hypnotic drugs in the last 2 weeks, or a 7-day cleansing period for those taking drugs.
Key exclusion criteria (6 listed)
- DSM-5 organic mood disorders; psychiatric disorders associated with somatic diseases; psychiatric disorders due to psychoactive substances.
- Those with contraindications to escitalopram, mianserin, lorazepam medications.
- family history of psychiatric or other somatic disorders.
- Those with excessive psychiatric symptoms unable to complete the interview or unable to understand the content of the scale
- Pregnant and lactating females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MianserinSubjects were required to take mianserin regularly during the study period, with the effective dose being taken orally once a night before bedtime. | Drug | Mianserin with escitalopram |
| LorazepamSubjects were required to take lorazepam regularly during the study period, with the effective dose being taken orally once a night before bedtime. | Drug | Lorazepam with escitalopram |
Primary outcome
Pittsburgh sleep quality index,PSQI
Time frame: 8 weeks
30% reduction in the PSQI scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mianserin and Lorazepam in people with Depression, run by Zhenghui YI at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index,PSQI (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.