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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013464
• Other study ID #: 2014-4-2113
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: July 2019
• Source: Peking University Sixth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 30, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Escitalopram
Escitalopram 10-20mg/d

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Sixth Hospital	National Institute on Drug Dependence, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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