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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Major depressive disorder compared to health control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDD and Health Control<br>MDD in open label | Drug: Escitalopram<br>* Escitalopram 10-20mg/d<br>* Other names: no other intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | 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. | 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. | 8 weeks |