Predictors of the Response and Relapse/Recurrence After ECT for Depressed Patients

NCT02032576 | Completed Phase 4 DMC

• 1 other identifier: KSPH-2008-12
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Psychiatrists have long sought a quantifiable biomarker of electroconvulsive therapy (ECT) response. Although ECT is highly effective for treatment of patients with major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. The purpose of this study is to examine the factors related to the response of ECT, to predict ECT response early, and to investigate the clinical predictors affecting the time to relapse/recurrence after ECT. Methods: Patients with major depressive episode who require ECT treatment will be enrolled. ECT will be performed regularly. The 17-item Hamilton Rating Scale for Depression (HAMD-17) and other scales will be assessed before ECT, after every 10 days, till to an expected average of 50 days, and monthly during the 6-month follow-up period. Other measures also will be performed before the first ECT, at an expected average of 50 days, and at the end of follow-up period. Predictors of the response and relapse/recurrence after ECT and early prediction of ECT response will be obtained by statistic methods.

Conditions

Major Depressive Episode

Keywords

major depressive episode, electroconvulsive therapy

Outcome Measures

Primary Outcomes (2)

• Predictors of ECT response

  Response will be defined as a reduction of 60% or more of the HAMD-17 score after treatment. Potential factors related to ECT response will be assayed. Early prediction model of response will be established.

  an expected average of 50 days after initiation of ECT

• Predictors of relapse/recurrence after ECT

  The definition of relapse/recurrence of the major depressive episode will be readmission or a HAMD-17 score at least 18. Predictors (demographic and clinical variables) associated with time to relapse/recurrence during the 6-month follow-up period will be assayed using survival analysis.

  After ECT, HAMD-17 will be assessed monthly until the relapse/recurrence of the major depressive episode during the 6-month follow-up period.

Secondary Outcomes (8)

• The changes of plasma brain-derived neurotrophic factor (BDNF) level after ECT

  Prior to undergoing the first ECT and at an expected average of 50 days, plasma BDNF will be tested.

• The changes of cognitive functions after ECT

  Neuropsychological test will be performed before the first ECT and at an expected average of 50 days.

• Assessments of safety for general adverse events after ECT

  UKU Side Effect Rating Scale will be assessed before ECT, after every 10 days, till to an expected average of 50 days.

• The changes of quality of life after ECT

  Short-Form 36 (SF-36) will be examined before the first ECT and at an expected average of 50 days.

• The changes of psychosocial functioning after ECT

  Work and Social Adjustment Scale (WSAS) will be examined before the first ECT and at an expected average of 50 days.

Study Arms (1)

ECT for depressed patients

EXPERIMENTAL

electroconvulsive therapy with a bipolar brief pulse square wave

Device: ECT for depressed patients

Interventions

ECT for depressed patients DEVICE

electroconvulsive therapy with a bipolar brief pulse square wave

Also known as: bilateral ECT with a bipolar brief pulse square wave

ECT for depressed patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of major depressive disorder or bipolar depression
• Poor drug response
• Severity or urgency of illness

You may not qualify if:

• Subjects cannot write the imform consents
• Subjects with severe physical illness

Sponsors & Collaborators

• Kaohsiung Kai-Suan Psychiatric Hospital: lead

Study Sites (1)

Kai-Suan Psychiatric Hospital

Kaohsiung City, 802, Taiwan

Location

Related Publications (3)

• Wahlund B, von Rosen D. ECT of major depressed patients in relation to biological and clinical variables: a brief overview. Neuropsychopharmacology. 2003 Jul;28 Suppl 1:S21-6. doi: 10.1038/sj.npp.1300135.

  PMID: 12827140 RESULT

• Bourgon LN, Kellner CH. Relapse of depression after ECT: a review. J ECT. 2000 Mar;16(1):19-31. doi: 10.1097/00124509-200003000-00003.

  PMID: 10735328 RESULT

• Marano CM, Phatak P, Vemulapalli UR, Sasan A, Nalbandyan MR, Ramanujam S, Soekadar S, Demosthenous M, Regenold WT. Increased plasma concentration of brain-derived neurotrophic factor with electroconvulsive therapy: a pilot study in patients with major depression. J Clin Psychiatry. 2007 Apr;68(4):512-7. doi: 10.4088/jcp.v68n0404.

  PMID: 17474805 RESULT

Study Officials

• Ching-Hua Lin, M.D.

  Kai-Suan Psychiatric Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Adult Psychiatry Department

Study Record Dates

• First Submitted: June 3, 2012
• First Posted: January 10, 2014
• Study Start: January 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

TW (1)