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出境医 / 临床实验 / Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder

Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Escitalopram Not Applicable

Detailed Description:
  1. 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.
  2. 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).
  3. Treatment: Each patient was provided with escitalopram.
  4. Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h intervals for 24 h from all participants.
  5. Sleep and EEG recordings: The PSG of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (MDD).
  6. Analysis the PSG architecture and power ratio.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : December 30, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: MDD and Health Control
MDD in open label
 Drug: Escitalopram
Escitalopram 10-20mg/d
Other Name: no other intervention
Outcome Measures
Primary Outcome Measures :
  1. 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 .

  2. 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.

  3. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   22 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Sponsors and Collaborators
Peking University Sixth Hospital
National Institute on Drug Dependence, China
Investigators
Layout table for investigator information
Principal Investigator: Su-Xia Li, Doctor National Institute on Drug Dependence, China
Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE May 1, 2016
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder
Official Title  ICMJE 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
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
  1. 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.
  2. 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).
  3. Treatment: Each patient was provided with escitalopram.
  4. Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h intervals for 24 h from all participants.
  5. Sleep and EEG recordings: The PSG of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (MDD).
  6. Analysis the PSG architecture and power ratio.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE Drug: Escitalopram
Escitalopram 10-20mg/d
Other Name: no other intervention
Study Arms  ICMJE Experimental: MDD and Health Control
MDD in open label
Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2019) 		31
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 22 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013464
Other Study ID Numbers  ICMJE 2014-4-2113
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xueqin Wang, Peking University Sixth Hospital
Study Sponsor  ICMJE Peking University Sixth Hospital
Collaborators  ICMJE National Institute on Drug Dependence, China
Investigators  ICMJE
Principal Investigator: Su-Xia Li, Doctor National Institute on Drug Dependence, China
PRS Account Peking University Sixth Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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