Effects of Escitalopram on the Sleep EEG Power in Patient... | NCT04013464

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

NCT04013464

Sponsor

Peking University Sixth Hospital

Status

Completed

Last Update Posted

Jul 9, 2019Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2016Actual

Primary Completion Date

May 31, 2018Actual

Completion Date

Dec 30, 2018Actual

First Submitted Date

Jun 26, 2019

First Submission Date that Met QC Criteria

Jul 6, 2019

First Posted Date

Jul 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2019

Last Update Posted Date

Jul 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xueqin Wang, Associate professor, M.D., Peking University Sixth HospitalPrincipal Investigator

Lead Sponsor

Peking University Sixth HospitalOTHER

Collaborators

Name	Class
National Institute on Drug Dependence, China	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.
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).
Treatment: Each patient was provided with escitalopram.
Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h intervals for 24 h from all participants.
Sleep and EEG recordings: The PSG of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (MDD).
Analysis the PSG architecture and power ratio.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MDD and Health Control	Experimental	MDD in open label	Drug: Escitalopram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	Escitalopram 10-20mg/d	MDD and Health Control	no other intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Su-Xia Li, Doctor	National Institute on Drug Dependence, China	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000089983	Escitalopram

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Browse Leaves

Not provided

Browse Branches

Not provided