Neurophysiologic Changes in Patients With Bipolar Depression

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Bipolar Depression

Treatments: Drug: Quetiapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01213121

SNUBH 11-2010-040

Details and patient eligibility

About

• To examine differences in neurophysiologic parameters between unmedicated patients with bipolar depression and healthy controls
• To examine within-subject changes in neurophysiologic parameters in patients with bipolar depression treated with quetiapine

Full description

• Alterations of neurophysiologic regulation has been suggested in patients with major depressive disorder or bipolar disorders
• Depressive phase of bipolar disorder shows multi-faceted characteristics different from unipolar depression
• Quetiapine is an atypical antipsychotic licensed for treatment of bipolar depression
• The aim of this study is to investigate the pattern of neurophysiologic dysregulation in bipolar depression and its changes induced by quetiapine treatment

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• DSM-IV bipolar disorder I or II
• Depressive phase
• Drug-naive or drug-free

Exclusion criteria

• Serious medical or neurological conditions
• DSM-IV substance-related disorders (within 12 months prior to participation)
• Mentally retarded

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

bipolar depression

Experimental group

Description:

unmedicated patients with bipolar depression receiving quetiapine treatment

Treatment:

Drug: Quetiapine

Control

No Intervention group

Description:

healthy controls matched for age, gender, and body mass index