Electroconvulsive Therapy in Clozapine-resistant Schizophrenia

NCT ID: NCT02159001

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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ECT treatment right after recruitment

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

Group Type ACTIVE_COMPARATOR

electroconvulsive therapy

Intervention Type DEVICE

10-course, three times a week bilateral frontotemporal ECT

ECT after 4 weeks period.

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

Group Type PLACEBO_COMPARATOR

electroconvulsive therapy

Intervention Type DEVICE

10-course, three times a week bilateral frontotemporal ECT

Interventions

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electroconvulsive therapy

10-course, three times a week bilateral frontotemporal ECT

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Niuvanniemi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Niuvanniemi Hospital

Kuopio, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Eila Tiihonen, MD, PhD

Role: CONTACT

+358 295 242 204

Soile Hyvärinen, MD

Role: CONTACT

+358 295 242 219

Facility Contacts

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Soile Hyvärinen, MD

Role: primary

+358 295 242 219

Other Identifiers

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22014

Identifier Type: -

Identifier Source: org_study_id

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