Clozapine Resistant SchizophreniaPhase 4NCT06501339
Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia
A Phase 4 study testing maintenance ECT and Aripiprazole tablet in people with Clozapine Resistant Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar.
Trial summary
The pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. Few studies have found ECT as beneficial in TRS, including CRS. However, literature on the role of M-ECT in maintaining the therapeutic gains of acute ECT in CRS is lacking. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Clozapine Resistant Schizophrenia
- What is being tested?
- maintenance ECT and Aripiprazole tablet
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 31 Mar 2026
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients clinically diagnosed with CRS (currently under clozapine)
- Patients aged 18-60 years of either sex.
- LAR giving voluntary written consent for participation in the study
Who cannot join
- Patient already on ECT or aripiprazole.
- History of psychoactive substance abuse or dependence.
- Co-morbid psychiatric, major medical or neurological disorders.
- History of organicity or significant head injury.
- Pacemaker or metal in any body part, excluding the mouth. Pregnant and breastfeeding females.
Trial locations and contacts
No sites are listed yet.
Debadatta Mohapatra, MD contact
About this study
Official title: Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole on Psychopathology and Cerebral Perfusion in Clozapine-resistant Schizophrenia: a Randomized, Double-blind Controlled Trial
The pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. Few studies have found ECT as beneficial in TRS, including CRS. However, literature on the role of M-ECT in maintaining the therapeutic gains of acute ECT in CRS is lacking. The objective of the study is to compare the efficacy of M-ECT vs aripiprazole as an add-on to ongoing clozapine on the severity of symptom dimensions, cerebral perfusion, global functioning and cognitions in patients with CRS.
- Conditions
- Clozapine Resistant Schizophrenia
- Being tested
- maintenance ECT, Aripiprazole tablet
- Keywords
- Clozapine resistant, schizophrenia, Aripiprazole, m-ECT
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintenance ECTProcedure or surgery
Frequency of weekly sessions for 1 month, then fortnightly for 5 months
Aripiprazole tabletDrug
Aripiprazole 10 mg in the morning throughout the study period
| Study group | Role | What they receive |
|---|---|---|
| Maintenance ECT | Experimental | Not described Receives: Procedure: maintenance ECT |
| Aripiprazole | Active comparator | Not described Receives: Drug: Aripiprazole tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive And Negative Syndome Scale score
Change from baseline in Total, Positive, negative and general scores with treatment. Minimum value: 30; maximum value: 210. Higher score means worsening of symptoms
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary outcomes (4)
Change in regional cerebral blood flow by the SPECT-CT brain
Change frome baseline in regional cerebral blood flow by the SPECT-CT brain with treatment
Measured: Baseline, 24 weeks
change in the Monteal Cognitive Assessment scores
change from baseline in the Monteal Cognitive Assessment scores with treatment. Minimum Value: 0 Maximum Value: 30: Higher score indicate better cognitive function
Measured: Baseline,6 weeks, 12 weeks, 24 weeks
change in the Global Assessment of Functioning scores
change from baseline in the Global Assessment of Functioning scores with treatment Minimum Value: 0 Maximum Value: 100: Higher score indicate better global functioning
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks
Safety evaluation
Number of events observed in each patient and patients with at least one adverse event
Measured: Baseline,6 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start10 Aug 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Clozapine Resistant 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BISWA RANJAN MISHRA, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Rituparna Maiti, MD, Study director, AIIMS Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501339
- Sponsor's protocol ID
- T/EMF/Psych/23-24/13
- Status last verified
- Jul 2024
- First submitted
- 14 Oct 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siskind D, Orr S, Sinha S, Yu O, Brijball B, Warren N, MacCabe JH, Smart SE, Kisely S. Rates of treatment-resistant schizophrenia from first-episode cohorts: systematic review and meta-analysis. Br J Psychiatry. 2022 Mar;220(3):115-120. doi: 10.1192/bjp.2021.61.
PubMed 35049446Siskind D, Siskind V, Kisely S. Clozapine Response Rates among People with Treatment-Resistant Schizophrenia: Data from a Systematic Review and Meta-Analysis. Can J Psychiatry. 2017 Nov;62(11):772-777. doi: 10.1177/0706743717718167. Epub 2017 Jun 28.
PubMed 28655284Campana M, Falkai P, Siskind D, Hasan A, Wagner E. Characteristics and definitions of ultra-treatment-resistant schizophrenia - A systematic review and meta-analysis. Schizophr Res. 2021 Feb;228:218-226. doi: 10.1016/j.schres.2020.12.002. Epub 2021 Jan 14.
PubMed 33454644Rey JM, Walter G. Half a century of ECT use in young people. Am J Psychiatry. 1997 May;154(5):595-602. doi: 10.1176/ajp.154.5.595.
PubMed 9137112Chanpattana W, Andrade C. ECT for treatment-resistant schizophrenia: a response from the far East to the UK. NICE report. J ECT. 2006 Mar;22(1):4-12. doi: 10.1097/00124509-200603000-00002.
PubMed 16633199
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole on Psychopathology and Cerebral Perfusion in Clozapine-resistant Schizophrenia: a Randomized, Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06501339
- Acronym / sponsor ID
- T/EMF/Psych/23-24/13
- Conditions
- Clozapine Resistant Schizophrenia
- Keywords
- Clozapine resistant, schizophrenia, Aripiprazole, m-ECT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 15 Jul 2024 (actual)
- 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 pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. Few studies have found ECT as beneficial in TRS, including CRS. However, literature on the role of M-ECT in maintaining the therapeutic gains of acute ECT in CRS is lacking. The objective of the study is to compare the efficacy of M-ECT vs aripiprazole as an add-on to ongoing clozapine on the severity of symptom dimensions, cerebral perfusion, global functioning and cognitions in patients with CRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance ECT | Experimental | Procedure: maintenance ECT |
| Aripiprazole | Active comparator | Drug: Aripiprazole tablet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients clinically diagnosed with CRS (currently under clozapine)
- Patients aged 18-60 years of either sex.
- LAR giving voluntary written consent for participation in the study
Key exclusion criteria (5 listed)
- Patient already on ECT or aripiprazole.
- History of psychoactive substance abuse or dependence.
- Co-morbid psychiatric, major medical or neurological disorders.
- History of organicity or significant head injury.
- Pacemaker or metal in any body part, excluding the mouth. Pregnant and breastfeeding females.
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 |
|---|---|---|
| maintenance ECTFrequency of weekly sessions for 1 month, then fortnightly for 5 months | Procedure or surgery | Maintenance ECT |
| Aripiprazole tabletAripiprazole 10 mg in the morning throughout the study period | Drug | Aripiprazole |
Primary outcome
Change in Positive And Negative Syndome Scale score
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Change from baseline in Total, Positive, negative and general scores with treatment. Minimum value: 30; maximum value: 210. Higher score means worsening of symptoms
4 secondary outcomes
Change in regional cerebral blood flow by the SPECT-CT brain
Time frame: Baseline, 24 weeks
change in the Monteal Cognitive Assessment scores
Time frame: Baseline,6 weeks, 12 weeks, 24 weeks
change in the Global Assessment of Functioning scores
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Safety evaluation
Time frame: Baseline,6 weeks, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 35049446Siskind D, Orr S, Sinha S, Yu O, Brijball B, Warren N, MacCabe JH, Smart SE, Kisely S. Rates of treatment-resistant schizophrenia from first-episode cohorts: systematic review and meta-analysis. Br J Psychiatry. 2022 Mar;220(3):115-120. doi: 10.1192/bjp.2021.61.
- Background: PubMed 28655284Siskind D, Siskind V, Kisely S. Clozapine Response Rates among People with Treatment-Resistant Schizophrenia: Data from a Systematic Review and Meta-Analysis. Can J Psychiatry. 2017 Nov;62(11):772-777. doi: 10.1177/0706743717718167. Epub 2017 Jun 28.
- Background: PubMed 33454644Campana M, Falkai P, Siskind D, Hasan A, Wagner E. Characteristics and definitions of ultra-treatment-resistant schizophrenia - A systematic review and meta-analysis. Schizophr Res. 2021 Feb;228:218-226. doi: 10.1016/j.schres.2020.12.002. Epub 2021 Jan 14.
- Background: PubMed 9137112Rey JM, Walter G. Half a century of ECT use in young people. Am J Psychiatry. 1997 May;154(5):595-602. doi: 10.1176/ajp.154.5.595.
- Background: PubMed 16633199Chanpattana W, Andrade C. ECT for treatment-resistant schizophrenia: a response from the far East to the UK. NICE report. J ECT. 2006 Mar;22(1):4-12. doi: 10.1097/00124509-200603000-00002.
- 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.
Debadatta Mohapatra, MD contact
Rituparna Maiti, MD study director
AIIMS Bhubaneswar
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing maintenance ECT and Aripiprazole tablet in people with Clozapine Resistant Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar.
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 3 inclusion and 5 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 Jul 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Biswa Ranjan Mishra, MD (9438884220, psych_biswa@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive And Negative Syndome Scale score (time frame: Baseline, 6 weeks, 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06501339, which also lists 5 linked publications.
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 Jul 2024.