Bifrontal and Bitemporal Electroconvulsive Therapy (ECT) in Treatment of Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT02511509
• Date of registration: 09/07/2015
• Prospective Registration: Yes
• Primary sponsor: Medical Universtity of Lodz
• Public title: Bifrontal and Bitemporal Electroconvulsive Therapy (ECT) in Treatment of Patients With Schizophrenia ESBECT
• Scientific title: Comparison of the Efficacy and Safety of the Bifrontal Electroconvulsive Therapy (ECT) and the Standard Bitemporal ECT in the Treatment of Patients With Schizophrenia
• Date of first enrolment: September 2015
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02511509
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Poland

Contacts

• Name: Jakub Kazmierski, PhD

• Name: Jakub Kazmierski, PhD

• Name: Iwona Kloszewska, Prof.
• Affiliation: Medical University of Lodz, Poland

Key inclusion & exclusion criteria

Inclusion Criteria:

- The patients who met Diagnostic and Statistical Manual-DSM-V criteria for
schizophrenia (apart from residual type)

- The patients qualified for ECT according the standard protocol

- Antipsychotic treatment with dibenzepins according to the following scheme: the dose
of clozapine not higher than 450mg, the dose of olanzapine not higher than 20mg and
the dose of quetiapine not higher than 600mg per day

- If needed concomitant treatment allowed with hydroxyzine (max. 100mg per day) and
lorazepam (max. 4mg per day)

- Anaesthesia conducted with the use of suxamethonium chloride, propofol and atropine

Exclusion Criteria:

- The lack of patient's consent

- Mental retardation confirmed with the psychological and psychiatric examination
(IQ<70; fulfilled DSM-V criteria for mental retardation)

- Dementia diagnosed on the basis of DSM-V criteria

- Substance abuse during the year prior study enrolment or substance addiction

- The presence of symptoms which met DSM-V criteria for affective episode (an episode
of mania, hypomania or depression)

- The ECT conducted during 6 months prior the study enrolment

- The history of previous ineffective ECT

- The need for antipsychotic treatment other than derivatives of dibenzothiazepines or
in doses higher than 450mg of clozapine, 20mg of olanzapine and 600mg of quetiapine
per day

- The women in the generative period who do not use effective contraception (sexual
abstinence, contraceptives, intrauterine device, mechanical contraceptive devices)

- The need for use of other than suxamethonium chloride, propofol and atropine
anaesthetics and concomitant medications



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Device: Bitemporal electroconvulsive therapy

Device: Bifrontal electroconvulsive therapy

Primary Outcome(s)

Clinical Global Impression [Time Frame: up to 5 weeks]

Positive and Negative Syndrome Scale [Time Frame: up to 5 weeks]

Finger Tapping Test [Time Frame: up to 5 weeks]

Shifting Attention Test [Time Frame: up to 5 weeks]

Symbol Digit Coding Test [Time Frame: up to 5 weeks]

Visual Memory Test [Time Frame: up to 5 weeks]

Confusion Assessment Method [Time Frame: up to 5 weeks]

Memorial Delirium Assessment Scale [Time Frame: up to 5 weeks]

Stroop Test [Time Frame: up to 5 weeks]

Continuous Performance Test [Time Frame: up to 5 weeks]

Verbal Memory Test [Time Frame: up to 5 weeks]

Secondary Outcome(s)

Positron Emission Tomography to assess the impact of ECT on the dopaminergic system activity [Time Frame: up to 5 weeks]

The concentration of brain-derived neurotrophic factor. [Time Frame: up to 5 weeks]

The concentration of neuron specific enolase. [Time Frame: up to 5 weeks]

The concentration of protein S100B [Time Frame: up to 5 weeks]

Secondary ID(s)

RNN/535/10/KB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors