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

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ClinicalTrials.gov Identifier: NCT04013464
Recruitment Status : Completed
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
National Institute on Drug Dependence, China
Information provided by (Responsible Party):
Xueqin Wang, Peking University Sixth Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MDD and Health Control
MDD in open label
Drug: Escitalopram
Escitalopram 10-20mg/d
Other Name: no other intervention




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013464


Sponsors and Collaborators
Peking University Sixth Hospital
National Institute on Drug Dependence, China
Investigators
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Principal Investigator: Su-Xia Li, Doctor National Institute on Drug Dependence, China

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Responsible Party: Xueqin Wang, Associate professor, M.D., Peking University Sixth Hospital
ClinicalTrials.gov Identifier: NCT04013464     History of Changes
Other Study ID Numbers: 2014-4-2113
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Citalopram
Dexetimide
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents