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Electroconvulsive Therapy in Clozapine-resistant Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
electroconvulsive therapy
Sponsored by
Niuvanniemi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring clozapine, ECT, PANSS, schizoaffective disorder, schizophrenia, treatment

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Niuvanniemi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ECT treatment right after recruitment

ECT after 4 weeks period.

Arm Description

This group receives electroconvulsive therapy treatment right after they are recruited.

This group receives electroconvulsive therapy treatment after 4 weeks waiting period.

Outcomes

Primary Outcome Measures

Positive and Negative Symptom Scale
Positive and Negative Symptom Scale (PANSS) is assessed two days after ECT course

Secondary Outcome Measures

Full Information

First Posted
June 4, 2014
Last Updated
October 15, 2015
Sponsor
Niuvanniemi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02159001
Brief Title
Electroconvulsive Therapy in Clozapine-resistant Schizophrenia
Official Title
Efficacy and Cognitive Effects of Electroconvulsive Therapy in Clozapine-Resistant Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niuvanniemi Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
clozapine, ECT, PANSS, schizoaffective disorder, schizophrenia, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECT treatment right after recruitment
Arm Type
Active Comparator
Arm Description
This group receives electroconvulsive therapy treatment right after they are recruited.
Arm Title
ECT after 4 weeks period.
Arm Type
Placebo Comparator
Arm Description
This group receives electroconvulsive therapy treatment after 4 weeks waiting period.
Intervention Type
Device
Intervention Name(s)
electroconvulsive therapy
Intervention Description
10-course, three times a week bilateral frontotemporal ECT
Primary Outcome Measure Information:
Title
Positive and Negative Symptom Scale
Description
Positive and Negative Symptom Scale (PANSS) is assessed two days after ECT course
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eila Tiihonen, MD, PhD
Phone
+358 295 242 204
Email
eila.tiihonen@niuva.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Soile Hyvärinen, MD
Phone
+358 295 242 219
Email
soile.hyvarinen@niuva.fi
Facility Information:
Facility Name
Niuvanniemi Hospital
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soile Hyvärinen, MD
Phone
+358 295 242 219
Email
soile.hyvarinen@niuva.fi
First Name & Middle Initial & Last Name & Degree
Soile Hyvärinen, MD
First Name & Middle Initial & Last Name & Degree
Eila Tiihonen, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Electroconvulsive Therapy in Clozapine-resistant Schizophrenia

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