NCT01213121

Brief Summary

  • 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

4.1 years

First QC Date

September 30, 2010

Last Update Submit

November 19, 2013

Conditions

Bipolar Depression

Keywords

bipolar depressionheart rate variabilitycardio-respiratory couplingelectroencephalography

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability

    heart rate variability parameters of time/frequency/complexity domains

    Six weeks

Secondary Outcomes (4)

  • Cardio-Respiratory Coupling

    Six weeks

  • Electroencephalographic Changes

    Six weeks

  • Severity of Mood Symptoms

    Six weeks

  • Severity of Extrapyramidal Symptom Scale

    Six weeks

Study Arms (2)

bipolar depression

EXPERIMENTAL

unmedicated patients with bipolar depression receiving quetiapine treatment

Drug: Quetiapine

Control

NO INTERVENTION

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

Interventions

QuetiapineDRUG

oral tablet/25-600mg per day/once a day/six weeks

Also known as: Seroquel
bipolar depression

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuropsychiatry, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (5)

  • Berger S, Boettger MK, Tancer M, Guinjoan SM, Yeragani VK, Bar KJ. Reduced cardio-respiratory coupling indicates suppression of vagal activity in healthy relatives of patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Mar 17;34(2):406-11. doi: 10.1016/j.pnpbp.2010.01.009. Epub 2010 Jan 18.

    PMID: 20083149BACKGROUND

  • Bar KJ, Schuhmacher A, Hofels S, Schulz S, Voss A, Yeragani VK, Maier W, Zobel A. Reduced cardio-respiratory coupling after treatment with nortriptyline in contrast to S-citalopram. J Affect Disord. 2010 Dec;127(1-3):266-73. doi: 10.1016/j.jad.2010.05.010. Epub 2010 Jun 9.

    PMID: 20538342BACKGROUND

  • Chang JS, Yoo CS, Yi SH, Hong KH, Oh HS, Hwang JY, Kim SG, Ahn YM, Kim YS. Differential pattern of heart rate variability in patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Aug 31;33(6):991-5. doi: 10.1016/j.pnpbp.2009.05.004. Epub 2009 May 7.

    PMID: 19427888BACKGROUND

  • Kemp AH, Quintana DS, Gray MA, Felmingham KL, Brown K, Gatt JM. Impact of depression and antidepressant treatment on heart rate variability: a review and meta-analysis. Biol Psychiatry. 2010 Jun 1;67(11):1067-74. doi: 10.1016/j.biopsych.2009.12.012. Epub 2010 Feb 6.

    PMID: 20138254BACKGROUND

  • Kemp AH, Gray MA, Silberstein RB, Armstrong SM, Nathan PJ. Augmentation of serotonin enhances pleasant and suppresses unpleasant cortical electrophysiological responses to visual emotional stimuli in humans. Neuroimage. 2004 Jul;22(3):1084-96. doi: 10.1016/j.neuroimage.2004.03.022.

    PMID: 15219580BACKGROUND

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jae Seung Chang, M.D., Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Seung Chang, M.D., Ph.D.

CONTACT

82-31-787-7437cjs0107@snu.ac.kr

Ji Sun Kim, M.D.

CONTACT

82-10-9933-1286ideal91@hanmail.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 1, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

KR(1)