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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04013464

Enrollment

Registered

2019-07-09

Start date

2016-05-01

Completion date

2018-12-30

Last updated

2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

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.

Interventions

DRUGEscitalopram

Escitalopram 10-20mg/d

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

changed into escitalopram in open treatment and compared to health control

Intervention model description

Major depressive disorder compared to health control

Eligibility

Sex/Gender

MALE

Age

22 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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 .
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026