Depressive Disorder, MajorNCT04013464
Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder
A study testing Escitalopram in people with Depressive Disorder, Major, run by Peking University Sixth Hospital.
Trial summary
The main objective was to compare the differences of PSG parameters and plasma melatonin levels before and after treatment with escitalopram for 8 weeks. Polysomnography (PSG) was detected over a night and blood samples were collected at 4 h intervals for 24 h from 13 male healthy controls and 13 male MDD patients… Read more about this study
- Who is it for?
- Ages 22 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 30 Dec 2018
- Phase
- Interventional
- 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 22 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of MDD;
- Hamilton Rating Scale for Depression 17-items (HRSD-17) total scores ≥ 22;
- Male patients aged between 18 and 45 years
Who cannot join
- Significant suicide risk by HRSD suicide scores > 2;
- Accompanied with psychiatric symptoms;
- Treated with MECT within 6 months.
About this study
Official title: Changes of Sleep EEG Power and Melatonin Rhythm in Major Depressive Disoder: a Self-controlled, 8 Weeks Study of Treatment With Escitalopram Compared With Healthy Subjects
The main objective was to compare the differences of PSG parameters and plasma melatonin levels before and after treatment with escitalopram for 8 weeks. Polysomnography (PSG) was detected over a night and blood samples were collected at 4 h intervals for 24 h from 13 male healthy controls and 13 male MDD patients before and after treatment with escitalopram for 8 weeks. The outcome measures included the levels of plasma melatonin, PSG parameters (include sleep architecture and power analysis) and scales.
Read the detailed description
- Design and participants: The patients with MDD were screened from the hospital, age- and gender-matched healthy controls were recruited by advertising from the community who signed written informed consent before participation.
- Assessments: The 17-item Hamilton Depression Rating Scale (HRSD-17) , Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression-Severity scale (CGI-S), and 14-item Hamilton anxiety scale (HAMA) were assessed at baseline and after 8 weeks' treatment with escitalopram for patients with MDD. As for healthy volunteer, these measures were evaluated only once. In addition, all participants were assessed Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI).
- Treatment: Each patient was provided with escitalopram.
- Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h intervals for 24 h from all participants.
- Sleep and EEG recordings: The PSG of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (MDD).
- Analysis the PSG architecture and power ratio.
- Conditions
- Depressive Disorder, Major
- Being tested
- Escitalopram
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called no other intervention
Escitalopram 10-20mg/d
| Study group | Role | What they receive |
|---|---|---|
| MDD and Health Control | Experimental | MDD in open label Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of MDD in the treatment of escitalopram
The 17-item Hamilton Depression Rating Scale (HRSD-17) was defined a prior as the primary outcome measure .
Measured: 8 weeks
Sleep ratio of EEG power changes in MDD after 8 weeks treatment by escitalopram
polysomnography (PSG) was detected over a night and power analysis was done.
Measured: 8 weeks
The levels changes of plasma melatonin after 8 weeks treatment by escitalopram
Test the levels of plasma melatonin at 7 time points during 24 h in MDD.
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 posted9 Jul 2019
- Study start1 May 2016
- Primary completion31 May 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Major depressive disorder compared to health control
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Dependence, China
- Responsible party
- Principal investigator, Xueqin Wang, Peking University Sixth Hospital
- Investigators
- Su-Xia Li, Doctor, Principal investigator, National Institute on Drug Dependence, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013464
- Sponsor's protocol ID
- 2014-4-2113
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Sleep EEG Power and Melatonin Rhythm in Major Depressive Disoder: a Self-controlled, 8 Weeks Study of Treatment With Escitalopram Compared With Healthy Subjects
- ClinicalTrials.gov ID
- NCT04013464
- Acronym / sponsor ID
- 2014-4-2113
- Conditions
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Dependence, China
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 9 Jul 2019 (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.
The main objective was to compare the differences of PSG parameters and plasma melatonin levels before and after treatment with escitalopram for 8 weeks. Polysomnography (PSG) was detected over a night and blood samples were collected at 4 h intervals for 24 h from 13 male healthy controls and 13 male MDD patients before and after treatment with escitalopram for 8 weeks. The outcome measures included the levels of plasma melatonin, PSG parameters (include sleep architecture and power analysis) and scales.
Detailed description
- Design and participants: The patients with MDD were screened from the hospital, age- and gender-matched healthy controls were recruited by advertising from the community who signed written informed consent before participation.
- Assessments: The 17-item Hamilton Depression Rating Scale (HRSD-17) , Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression-Severity scale (CGI-S), and 14-item Hamilton anxiety scale (HAMA) were assessed at baseline and after 8 weeks' treatment with escitalopram for patients with MDD. As for healthy volunteer, these measures were evaluated only once. In addition, all participants were assessed Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI).
- Treatment: Each patient was provided with escitalopram.
- Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h intervals for 24 h from all participants.
- Sleep and EEG recordings: The PSG of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (MDD).
- Analysis the PSG architecture and power ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Major depressive disorder compared to health control
| Arm | Type | Receives |
|---|---|---|
| MDD and Health Control | Experimental | Drug: EscitalopramMDD in open label |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of MDD;
- Hamilton Rating Scale for Depression 17-items (HRSD-17) total scores ≥ 22;
- Male patients aged between 18 and 45 years
Key exclusion criteria (3 listed)
- Significant suicide risk by HRSD suicide scores > 2;
- Accompanied with psychiatric symptoms;
- Treated with MECT within 6 months.
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 |
|---|---|---|
| EscitalopramAlso: no other interventionEscitalopram 10-20mg/d | Drug | MDD and Health Control |
Primary outcome
Clinical efficacy of MDD in the treatment of escitalopram
Time frame: 8 weeks
The 17-item Hamilton Depression Rating Scale (HRSD-17) was defined a prior as the primary outcome measure .
Sleep ratio of EEG power changes in MDD after 8 weeks treatment by escitalopram
Time frame: 8 weeks
polysomnography (PSG) was detected over a night and power analysis was done.
The levels changes of plasma melatonin after 8 weeks treatment by escitalopram
Time frame: 8 weeks
Test the levels of plasma melatonin at 7 time points during 24 h in MDD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Su-Xia Li, Doctor principal investigator
National Institute on Drug Dependence, China
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Depressive Disorder, Major, run by Peking University Sixth Hospital.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy of MDD in the treatment of escitalopram (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 9 Jul 2019.