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

Not Applicable

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Escitalopram

• Registration Number: NCT04013464
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-12-30
• Study First Submitted: 2019-06-26
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-06
• Last Update Submitted: 2019-07-06
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDD and Health Control	Escitalopram	MDD in open label

Primary Outcome Measures

Name	Time	Method
Sleep ratio of EEG power changes in MDD after 8 weeks treatment by escitalopram	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	8 weeks	Test the levels of plasma melatonin at 7 time points during 24 h in MDD.
Clinical efficacy of MDD in the treatment of escitalopram	8 weeks	The 17-item Hamilton Depression Rating Scale (HRSD-17) was defined a prior as the primary outcome measure .