NCT02159001

Brief Summary

Electroconvulsive therapy (ECT) is one of the oldest neuromodulation treatments still used in psychiatry. Only case reports and open label non-randomized studies have been published of ECT in clozapine-resistant schizophrenia patients. The purpose of this trial is to study the efficacy and cognitive effects of add-on ECT treatment (10-course) in schizophrenia patients taking clozapine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

3.5 years

First QC Date

June 4, 2014

Last Update Submit

October 15, 2015

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

clozapineECTPANSSschizoaffective disorderschizophreniatreatment

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Symptom Scale

    Positive and Negative Symptom Scale (PANSS) is assessed two days after ECT course

    2 days

Study Arms (2)

ECT treatment right after recruitment

ACTIVE COMPARATOR

This group receives electroconvulsive therapy treatment right after they are recruited.

Device: electroconvulsive therapy

ECT after 4 weeks period.

PLACEBO COMPARATOR

This group receives electroconvulsive therapy treatment after 4 weeks waiting period.

Device: electroconvulsive therapy

Interventions

electroconvulsive therapyDEVICE

10-course, three times a week bilateral frontotemporal ECT

ECT after 4 weeks period.ECT treatment right after recruitment

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of schizophrenia or schizoaffective disorder
  • treatment-resistant to clozapine
  • age 18 - 64 years
  • capacity and willingness to give informed consent

You may not qualify if:

  • serious somatic illness
  • progressive neurological illness, recent brain damage or sequela of serious brain damage
  • ECT less than 3 months prior to this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niuvanniemi Hospital

Kuopio, Finland

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Eila Tiihonen, MD, PhD

CONTACT

+358 295 242 204eila.tiihonen@niuva.fi

Soile Hyvärinen, MD

CONTACT

+358 295 242 219soile.hyvarinen@niuva.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 9, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

FI(1)