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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01948999

Enrollment

Registered

2013-09-24

Start date

2013-12-31

Completion date

2016-12-31

Last updated

2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment-refractory Schizophrenia

Keywords

electroconvulsive therapy, treatment-refractory schizophrenia

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.

Detailed description

The purpose of the study is not achieved.

Interventions

PROCEDUREECT

Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis

PROCEDURESHAM ECT

Anesthesia and concomitant muscular paralysis

DRUGAnesthesia

Temporary induced state of analgesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction in total PANSS score and adverse events	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.	PANSS = Positive and Negative Syndrome Scale and UKU = The UKU (Udvalg for Kliniske Undersøgelser) side effect rating scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026