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Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase

A

Asan Medical Center

Status

Completed

Conditions

Subsyndromal Depressive Phase
Bipolar Disorder
Heart Rate Variability

Study type

Observational

Funder types

Other

Identifiers

NCT01455038
A090116

Details and patient eligibility

About

The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability.

Enrollment

92 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Bipolar group:

    • DSM-IV bipolar disorder
    • Montgomery-Åsberg depression rating scale (MADRS) score for last one month : ≤ 10
    • Clinical Global Impression severity (CGI-S) for last one month : ≤ 3
  2. Healthy controls group: Subjects had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.

Exclusion criteria

  • Psychiatric disorder except bipolar disorder
  • Neurological symptoms or signs
  • History of head trauma
  • History of cardiovascular diseases
  • Any medication except psychiatric medication.

Trial design

92 participants in 2 patient groups

Control group
Description:
Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.
Bipolar group
Description:
individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale score of 10 or less and Clinical Global Impression severity of 3 or less for last one month.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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