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NCT02159001 Clinical Trial

Electroconvulsive Therapy in Clozapine-resistant Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02159001
Other study ID # 22014
Secondary ID
Status Recruiting
Phase N/A
First received June 4, 2014
Last updated October 15, 2015
Start date June 2014
Est. completion date June 2018

Study information
Verified date October 2015
Source Niuvanniemi Hospital
Contact Eila Tiihonen, MD, PhD
Phone +358 295 242 204
Email eila.tiihonen@niuva.fi
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• electroconvulsive therapy
10-course, three times a week bilateral frontotemporal ECT

Locations
Country Name City State
Finland Niuvanniemi Hospital Kuopio

Sponsors (1)
Lead Sponsor Collaborator
Niuvanniemi Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positive and Negative Symptom Scale Positive and Negative Symptom Scale (PANSS) is assessed two days after ECT course 2 days No
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