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Status unknownNCT02159001Updated Oct 16, 2015

Electroconvulsive Therapy in Clozapine-resistant Schizophrenia

An interventional study of electroconvulsive therapy in Schizophrenia and Schizoaffective Disorder, sponsored by Niuvanniemi Hospital. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-10-16.

Sponsored by Niuvanniemi Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder

Keywords

  • clozapine
  • ECT
  • PANSS
  • schizoaffective disorder
  • schizophrenia
  • treatment
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Niuvanniemi Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • serious somatic illness
  • progressive neurological illness, recent brain damage or sequela of serious brain damage
  • ECT less than 3 months prior to this trial
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    ECT treatment right after recruitment

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

    Device: electroconvulsive therapy

  • Placebo comparator
    ECT after 4 weeks period.

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

    Device: electroconvulsive therapy

Interventions

  • Deviceelectroconvulsive therapy

    10-course, three times a week bilateral frontotemporal ECT

06

What researchers measure

Primary outcomes

  1. Positive and Negative Symptom Scale

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

    Time frame: 2 days

07

Study locations

1 of 1 sites recruiting
  • Niuvanniemi Hospital
    Kuopio, Finland
    • Soile Hyvärinen, MD · Contact · soile.hyvarinen@niuva.fi · +358 295 242 219
    • Soile Hyvärinen, MD · Sub investigator
    • Eila Tiihonen, MD, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02159001
Lead sponsor
Niuvanniemi Hospital
Responsible party
Sponsor
First posted
Jun 9, 2014
Start date
Jun 2014
Primary completion
Dec 2017 (estimated)
Completion
Jun 2018 (estimated)
Last update
Oct 16, 2015

Study contacts

Eila Tiihonen, MD, PhD
Contact
eila.tiihonen@niuva.fi
+358 295 242 204
Soile Hyvärinen, MD
Contact
soile.hyvarinen@niuva.fi
+358 295 242 219

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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