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

NCT04013464 | Completed DMC

• 1 other identifier: 2014-4-2113
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

MDD and Health Control

EXPERIMENTAL

MDD in open label

Drug: Escitalopram

Interventions

Escitalopram DRUG

Escitalopram 10-20mg/d

Also known as: no other intervention

MDD and Health Control

Eligibility Criteria

• Age: 22 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of MDD;
• Hamilton Rating Scale for Depression 17-items (HRSD-17) total scores ≥ 22;
• Male patients aged between 18 and 45 years

You may not qualify if:

• Significant suicide risk by HRSD suicide scores \> 2;
• Accompanied with psychiatric symptoms;
• Treated with MECT within 6 months.

Sponsors & Collaborators

• Peking University Sixth Hospital: lead
• National Institute on Drug Dependence, China: collaborator

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Su-Xia Li, Doctor

  National Institute on Drug Dependence, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: changed into escitalopram in open treatment and compared to health control
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, M.D.

Model Details: Major depressive disorder compared to health control

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 9, 2019
• Study Start: May 1, 2016
• Primary Completion: May 31, 2018
• Study Completion: December 30, 2018
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share