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

NCT01948999 | Terminated

• 1 other identifier: N-20100085
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Treatment-refractory Schizophrenia

Keywords

electroconvulsive therapy; treatment-refractory schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

ECT

ACTIVE COMPARATOR

Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis

Procedure: ECT; Drug: Anesthesia

SHAM ECT

SHAM COMPARATOR

Anesthesia and concomitant muscular paralysis

Procedure: SHAM ECT; Drug: Anesthesia

Interventions

ECT PROCEDURE

Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis

ECT

SHAM ECT PROCEDURE

Anesthesia and concomitant muscular paralysis

SHAM ECT

Anesthesia DRUG

Temporary induced state of analgesia

ECT; SHAM ECT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed informed consent and power of attorney

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: September 24, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share