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

NCT ID: NCT04013464

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2018-12-30

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.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MDD and Health Control

MDD in open label

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

Escitalopram 10-20mg/d

Interventions

Escitalopram

Escitalopram 10-20mg/d

Intervention Type: DRUG

Other Intervention Names

no other intervention

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Dependence, China

OTHER

Sponsor Role: collaborator

Peking University Sixth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xueqin Wang

Associate professor, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Su-Xia Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

National Institute on Drug Dependence, China

Other Identifiers

2014-4-2113

Identifier Type: -

Identifier Source: org_study_id