Electroconvulsive Therapy in Clozapine-resistant Schizophrenia

October 15, 2015 updated by: Niuvanniemi Hospital

Efficacy and Cognitive Effects of Electroconvulsive Therapy in Clozapine-Resistant Schizophrenia

Electroconvulsive therapy (ECT) is one of the oldest neuromodulation treatments still used in psychiatry. Only case reports and open label non-randomized studies have been published of ECT in clozapine-resistant schizophrenia patients. The purpose of this trial is to study the efficacy and cognitive effects of add-on ECT treatment (10-course) in schizophrenia patients taking clozapine.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland
        • Recruiting
        • Niuvanniemi Hospital
        • Contact:
        • Sub-Investigator:
          • Soile Hyvärinen, MD
        • Principal Investigator:
          • Eila Tiihonen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of schizophrenia or schizoaffective disorder
  • treatment-resistant to clozapine
  • age 18 - 64 years
  • capacity and willingness to give informed consent

Exclusion Criteria:

  • serious somatic illness
  • progressive neurological illness, recent brain damage or sequela of serious brain damage
  • ECT less than 3 months prior to this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ECT treatment right after recruitment
This group receives electroconvulsive therapy treatment right after they are recruited.
Device: electroconvulsive therapy
10-course, three times a week bilateral frontotemporal ECT
PLACEBO_COMPARATOR: ECT after 4 weeks period.
This group receives electroconvulsive therapy treatment after 4 weeks waiting period.
Device: electroconvulsive therapy
10-course, three times a week bilateral frontotemporal ECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Symptom Scale
Time Frame: 2 days
Positive and Negative Symptom Scale (PANSS) is assessed two days after ECT course
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niuvanniemi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (ESTIMATE)

June 9, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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