Treatment-refractory SchizophreniaNCT01948999
Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study
A study testing ECT and Anesthesia in people with Treatment-refractory Schizophrenia, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-refractory Schizophrenia
- What is being tested?
- ECT and Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- Use of antiepileptic
- Previous no effect on psychotic symptoms after ECT treatment (minimum 15 ECT- treatments)
- Concrete suicidal plans
About this study
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.
Read the detailed description
The purpose of the study is not achieved.
- Conditions
- Treatment-refractory Schizophrenia
- Being tested
- ECT, SHAM ECT, Anesthesia
- Keywords
- electroconvulsive therapy, treatment-refractory schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECTProcedure or surgery
Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis
SHAM ECTProcedure or surgery
Anesthesia and concomitant muscular paralysis
AnesthesiaDrug
Temporary induced state of analgesia
| Study group | Role | What they receive |
|---|---|---|
| ECT | Active comparator | Electroconvulsive Therapy Anesthesia and concomitant muscular paralysis Receives: Procedure: ECT; Drug: Anesthesia |
| SHAM ECT | Sham comparator | Anesthesia and concomitant muscular paralysis Receives: Procedure: SHAM ECT; Drug: Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in total PANSS score and adverse events
PANSS = Positive and Negative Syndrome Scale and UKU = The UKU (Udvalg for Kliniske Undersøgelser) side effect rating scale
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Missing ressources. The study official has left and will not be replaced
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-refractory 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948999
- Sponsor's protocol ID
- N-20100085
- Status last verified
- Dec 2016
- First submitted
- 17 Jun 2013
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroconvulsive Therapy for Treatment Refractory Schizophrenia - A Randomized, Double-blinded, Sham-controlled Study
- ClinicalTrials.gov ID
- NCT01948999
- Acronym / sponsor ID
- N-20100085
- Conditions
- Treatment-refractory Schizophrenia
- Keywords
- electroconvulsive therapy, treatment-refractory schizophrenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Missing ressources. The study official has left and will not be replaced
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Sep 2013 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECT | Active comparator | Procedure: ECT, Drug: AnesthesiaElectroconvulsive Therapy Anesthesia and concomitant muscular paralysis |
| SHAM ECT | Sham comparator | Procedure: SHAM ECT, Drug: AnesthesiaAnesthesia and concomitant muscular paralysis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- Significant substance abuse
- Somatic disease that increases the risk of complications of ECT/anesthesia
- Epilepsy
- For women: Pregnancy or breast-feeding
- Homelessness
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 |
|---|---|---|
| ECTElectroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis | Procedure or surgery | ECT |
| SHAM ECTAnesthesia and concomitant muscular paralysis | Procedure or surgery | SHAM ECT |
| AnesthesiaTemporary induced state of analgesia | Drug | ECT, SHAM ECT |
Primary outcome
Reduction in total PANSS score and adverse events
Time frame: 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
Results and safety
The study was stopped early (reason given: Missing ressources. The study official has left and will not be replaced). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ECT and Anesthesia in people with Treatment-refractory Schizophrenia, run by University of Aarhus.
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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Missing ressources. The study official has left and will not be replaced). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in total PANSS score and adverse events (time frame: 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.). 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 20 Dec 2016.