search
Back to results

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
Peking University Sixth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

22 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Clinical diagnosis of MDD;
  2. Hamilton Rating Scale for Depression 17-items (HRSD-17) total scores ≥ 22;
  3. Male patients aged between 18 and 45 years

Exclusion Criteria:

  1. Significant suicide risk by HRSD suicide scores > 2;
  2. Accompanied with psychiatric symptoms;
  3. 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

    First Posted
    June 26, 2019
    Last Updated
    July 6, 2019
    Sponsor
    Peking University Sixth Hospital
    Collaborators
    National Institute on Drug Dependence, China
    search

    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

    We'll reach out to this number within 24 hrs