SchizophreniaNCT02159001
Electroconvulsive Therapy in Clozapine-resistant Schizophrenia
A study testing electroconvulsive therapy in people with Schizophrenia and Schizoaffective Disorder, run by Niuvanniemi Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- electroconvulsive therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of schizophrenia or schizoaffective disorder
- treatment-resistant to clozapine
- age 18 - 64 years
- capacity and willingness to give informed consent
Who cannot join
- serious somatic illness
- progressive neurological illness, recent brain damage or sequela of serious brain damage
- ECT less than 3 months prior to this trial
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Niuvanniemi Hospital
Kuopio
Soile Hyvärinen, MD, +358 295 242 219, soile.hyvarinen@niuva.fi
Soile Hyvärinen, MD
About this study
Official title: Efficacy and Cognitive Effects of Electroconvulsive Therapy in Clozapine-Resistant Schizophrenia
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- electroconvulsive therapy
- Keywords
- clozapine, ECT, PANSS, schizoaffective disorder, schizophrenia, treatment
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroconvulsive therapyDevice
10-course, three times a week bilateral frontotemporal ECT
| Study group | Role | What they receive |
|---|---|---|
| ECT treatment right after recruitment | Active comparator | This group receives electroconvulsive therapy treatment right after they are recruited. Receives: Device: electroconvulsive therapy |
| ECT after 4 weeks period. | Placebo comparator | This group receives electroconvulsive therapy treatment after 4 weeks waiting period. Receives: Device: electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale
Positive and Negative Symptom Scale (PANSS) is assessed two days after ECT course
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niuvanniemi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159001
- Sponsor's protocol ID
- 22014
- Status last verified
- Oct 2015
- First submitted
- 4 Jun 2014
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cognitive Effects of Electroconvulsive Therapy in Clozapine-Resistant Schizophrenia
- ClinicalTrials.gov ID
- NCT02159001
- Acronym / sponsor ID
- 22014
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- clozapine, ECT, PANSS, schizoaffective disorder, schizophrenia, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Niuvanniemi HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECT treatment right after recruitment | Active comparator | Device: electroconvulsive therapyThis group receives electroconvulsive therapy treatment right after they are recruited. |
| ECT after 4 weeks period. | Placebo comparator | Device: electroconvulsive therapyThis group receives electroconvulsive therapy treatment after 4 weeks waiting period. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosis of schizophrenia or schizoaffective disorder
- treatment-resistant to clozapine
- age 18 - 64 years
- capacity and willingness to give informed consent
Key exclusion criteria (3 listed)
- serious somatic illness
- progressive neurological illness, recent brain damage or sequela of serious brain damage
- ECT less than 3 months prior to this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroconvulsive therapy10-course, three times a week bilateral frontotemporal ECT | Device | ECT after 4 weeks period., ECT treatment right after recruitment |
Primary outcome
Positive and Negative Symptom Scale
Time frame: 2 days
Positive and Negative Symptom Scale (PANSS) is assessed two days after ECT course
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroconvulsive therapy in people with Schizophrenia and Schizoaffective Disorder, run by Niuvanniemi Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eila Tiihonen, MD, PhD (+358 295 242 204, eila.tiihonen@niuva.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Symptom Scale (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015; AzTrials last refreshed its copy on 1 Nov 2026.