Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of MDD;
- Hamilton Rating Scale for Depression 17-items (HRSD-17) total scores ≥ 22;
- Male patients aged between 18 and 45 years
Exclusion Criteria:
- Significant suicide risk by HRSD suicide scores > 2;
- Accompanied with psychiatric symptoms;
- Treated with MECT within 6 months.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MDD and Health Control
Arm Description
MDD in open label
Outcomes
Primary Outcome Measures
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 .
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04013464
First Posted
June 26, 2019
Last Updated
July 6, 2019
Sponsor
Peking University Sixth Hospital
Collaborators
National Institute on Drug Dependence, China
1. Study Identification
Unique Protocol Identification Number
NCT04013464
Brief Title
Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Sixth Hospital
Collaborators
National Institute on Drug Dependence, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Major depressive disorder compared to health control
Masking
None (Open Label)
Masking Description
changed into escitalopram in open treatment and compared to health control
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MDD and Health Control
Arm Type
Experimental
Arm Description
MDD in open label
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
no other intervention
Intervention Description
Escitalopram 10-20mg/d
Primary Outcome Measure Information:
Title
Clinical efficacy of MDD in the treatment of escitalopram
Description
The 17-item Hamilton Depression Rating Scale (HRSD-17) was defined a prior as the primary outcome measure .
Time Frame
8 weeks
Title
Sleep ratio of EEG power changes in MDD after 8 weeks treatment by escitalopram
Description
polysomnography (PSG) was detected over a night and power analysis was done.
Time Frame
8 weeks
Title
The levels changes of plasma melatonin after 8 weeks treatment by escitalopram
Description
Test the levels of plasma melatonin at 7 time points during 24 h in MDD.
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of MDD;
Hamilton Rating Scale for Depression 17-items (HRSD-17) total scores ≥ 22;
Male patients aged between 18 and 45 years
Exclusion Criteria:
Significant suicide risk by HRSD suicide scores > 2;
Accompanied with psychiatric symptoms;
Treated with MECT within 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-Xia Li, Doctor
Organizational Affiliation
National Institute on Drug Dependence, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder
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