Neurophysiologic Changes in Patients With Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01213121
• Other study ID #: SNUBH 11-2010-040
• Status: Recruiting
• Phase: Phase 4
• First received: September 30, 2010
• Last updated: November 19, 2013
• Start date: September 2010
• Est. completion date: October 2015

Study information

• Verified date: November 2013
• Source: Seoul National University Bundang Hospital
• Contact: Jae Seung Chang, M.D., Ph.D.
• Phone: 82-31-787-7437
• Email: cjs0107[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Quetiapine
oral tablet/25-600mg per day/once a day/six weeks

Locations

Country	Name	City	State
Korea, Republic of	Department of Neuropsychiatry, Seoul National University Bundang Hospital	Seongnam-Si	Gyeonggi-Do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Bär KJ, Schuhmacher A, Höfels 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. — View Citation

Berger S, Boettger MK, Tancer M, Guinjoan SM, Yeragani VK, Bär 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability	heart rate variability parameters of time/frequency/complexity domains	Six weeks	Yes
Secondary	Cardio-Respiratory Coupling	integrative parameters of interaction between neurocardiac dynamics and respiratory rhythm	Six weeks	Yes
Secondary	Electroencephalographic Changes	Electrical brain activities measured by quantitative electroencephalography	Six weeks	Yes
Secondary	Severity of Mood Symptoms	Hamilton Depression Rating Scale; Bipolar Depression Rating Scale; Young Mania Rating Scale; Difficulties in Emotion Regulation Scale; Emotion Regulation Questionnaire	Six weeks	No
Secondary	Severity of Extrapyramidal Symptom Scale	Drug-Induced Extrapyramidal Symptom Scale	Six weeks	Yes

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