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Completed

NCT Number: NCT04013464

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

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.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

22 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

Escitalopram 10-20mg/d

Other names: no other intervention

Primary outcomes

  1. Clinical efficacy of MDD in the treatment of escitalopram

    Time frame: 8 weeks

    The 17-item Hamilton Depression Rating Scale (HRSD-17) was defined a prior as the primary outcome measure .

  2. Sleep ratio of EEG power changes in MDD after 8 weeks treatment by escitalopram

    Time frame: 8 weeks

    polysomnography (PSG) was detected over a night and power analysis was done.

  3. The levels changes of plasma melatonin after 8 weeks treatment by escitalopram

    Time frame: 8 weeks

    Test the levels of plasma melatonin at 7 time points during 24 h in MDD.

Sponsors and collaborators

Lead sponsor

Peking University Sixth Hospital

Other

Collaborators

  • National Institute on Drug Dependence, China

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2019
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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