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

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Escitalopram

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: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDD and Health Control; MDD in open label	Drug: Escitalopram; Escitalopram 10-20mg/d; Other Names: no other intervention

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 6, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 6, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: 2014-4-2113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No