Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study

Treatment-refractory Schizophrenia Clinical Trial

Official title:

Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01948999
• Other study ID #: N-20100085
• Status: Terminated
• Phase: N/A
• First received: June 17, 2013
• Last updated: December 19, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether addition of electroconvulsive therapy to antipsychotic treatment improves the mental health of patients with treatment-resistant schizophrenia.

Description:

The purpose of the study is not achieved.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• An ICD-10 schizophrenia diagnosis F20.0-20.3 or F20.9

• PANSS total score >= 70

• CGI-S >= 4 (Clinical Global Impression)

• PANSS score >= 4 on minimum 2 og the following items: Delusions, Conceptual disorganization,Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness, Hostility, Disorientation.

• Previous/current treated with clozapine or refused clozapine treatment

• Lack of response to at least three different antipsychotics

• New antipsychotic medication prescribed more than 8 weeks before inclusion

• Fixed dosage of antipsychotics 1 month before inclusion

• No chance of additional neurotropic 4 weeks before inclusion

• Signed informed consent and power of attorney

Exclusion Criteria:

• Significant substance abuse

• Somatic disease that increases the risk of complications of ECT/anesthesia

• Epilepsy

• For women: Pregnancy or breast-feeding

• Homelessness

• Use of benzodiazepines (apart from tbl. oxazepam 10 mg., max 30 mg. daily)

• Use of antiepileptic

• Previous no effect on psychotic symptoms after ECT treatment (minimum 15 ECT- treatments)

• Concrete suicidal plans

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Treatment-refractory Schizophrenia

Intervention

Procedure:
• ECT
Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis
• SHAM ECT
Anesthesia and concomitant muscular paralysis

Drug:
• Anesthesia
Temporary induced state of analgesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in total PANSS score and adverse events	PANSS = Positive and Negative Syndrome Scale and UKU = The UKU (Udvalg for Kliniske Undersøgelser) side effect rating scale	The primary outcome will be assessed at screening, baseline and after every second week up to 72 weeks depending on the process for the individaul participant.	Yes