- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02159001
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 Contact
- Name: Eila Tiihonen, MD, PhD
- Phone Number: +358 295 242 204
- Email: eila.tiihonen@niuva.fi
Study Contact Backup
- Name: Soile Hyvärinen, MD
- Phone Number: +358 295 242 219
- Email: soile.hyvarinen@niuva.fi
Study Locations
-
-
-
Kuopio, Finland
- Recruiting
- Niuvanniemi Hospital
-
Contact:
- Soile Hyvärinen, MD
- Phone Number: +358 295 242 219
- Email: soile.hyvarinen@niuva.fi
-
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.
|
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.
|
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
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
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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