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

NCT ID: NCT01948999

Last Updated: 2016-12-20

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

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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The purpose of the study is not achieved.

Conditions

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Treatment-refractory Schizophrenia

Keywords

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electroconvulsive therapy treatment-refractory schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ECT

Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis

Group Type ACTIVE_COMPARATOR

ECT

Intervention Type PROCEDURE

Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis

Anesthesia

Intervention Type DRUG

Temporary induced state of analgesia

SHAM ECT

Anesthesia and concomitant muscular paralysis

Group Type SHAM_COMPARATOR

SHAM ECT

Intervention Type PROCEDURE

Anesthesia and concomitant muscular paralysis

Anesthesia

Intervention Type DRUG

Temporary induced state of analgesia

Interventions

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ECT

Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis

Intervention Type PROCEDURE

SHAM ECT

Anesthesia and concomitant muscular paralysis

Intervention Type PROCEDURE

Anesthesia

Temporary induced state of analgesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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Denmark

Other Identifiers

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N-20100085

Identifier Type: -

Identifier Source: org_study_id