Clinical trial NCT04013464: Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Lead sponsor: Peking University Sixth Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Dependence, China
First posted: 2019-07-09
Enrollment: 31
Sex: MALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Major depressive disorder compared to health control
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical efficacy of MDD in the treatment of escitalopram
timeFrame: 8 weeks
measure: Sleep ratio of EEG power changes in MDD after 8 weeks treatment by escitalopram
timeFrame: 8 weeks
measure: The levels changes of plasma melatonin after 8 weeks treatment by escitalopram
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Institute on Drug Dependence, China
name: Su-Xia Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: