Schizophrenia DisordersULTECNCT06972745
Efficacy & Tolerability of Rigth Unilateral vs. Bitemporal ECT in Schizophrenia in a Psychiatric Hospital in Mexico
A study testing Ultrabrief pulse electroconvulsive therapy and Brief pulse Electroconvulsive therapy in people with Schizophrenia Disorders, run by Hospital Psiquiátrico Fray Bernardino Álvarez at 1 site in Mexico.
Trial summary
Electroconvulsive therapy (ECT) is an established treatment for medication-resistant schizophrenia. There is debate about the best method of electrode placement. Bitemporal (BT) placement is commonly used for schizophrenia, while right unilateral (RUL) placement in mood disorders is associated with fewer adverse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia Disorders
- What is being tested?
- Ultrabrief pulse electroconvulsive therapy and Brief pulse Electroconvulsive therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteMexico
- Study dates
- 16 Mar 2023to 16 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria:
- Spanish-speaking.
- any sex/gender.
- Aged ≥18 years.
- Diagnosis of schizophrenia per DSM-5 criteria. 4. Baseline PANSS (Positive and Negative Syndrome Scale) total score ≥60. 5. Treatment with 1-2 antipsychotics (including clozapine).
B)Exclusion Criteria:
- Received ECT (electroconvulsive therapy) within the previous 3 months.
- Comorbid affective disorders (e.g., bipolar disorder, major depressive disorder).
- Catatonia or catatonic syndrome.
- Pregnancy
- Contraindications to general anesthesia/ECT (i.e. uncontrolled cardiovascular disease or intracranial hypertension).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cohort Study on Efficacy and Tolerance of Right Unilateral Electroconvulsive Therapy vs. Bitemporal in Patients With Paranoid Schizophrenia in Acute Psychosis at Fray Bernardino Álvarez Psychiatric Hospital
Electroconvulsive therapy (ECT) is an established treatment for medication-resistant schizophrenia. There is debate about the best method of electrode placement. Bitemporal (BT) placement is commonly used for schizophrenia, while right unilateral (RUL) placement in mood disorders is associated with fewer adverse effects on memory and language. This study compares the efficacy, safety and cognitive effects of BT-ECT versus RUL-ECT in hospitalized schizophrenia patients with acute psychosis.
Main Question: Does RUL-ECT reduce psychotic symptoms with fewer cognitive effects versus BT-ECT in patients with severe schizophrenia? Hypothesis: RUL-ECT is as effective as BT-ECT in reducing psychotic symptoms with fewer cognitive effects.
Methods: Randomized trial in patients with schizophrenia (confirmed by DSM 5 criteria) and severe symptoms (PANSS score ≥60). Patients were assigned to receive BT-ECT or RUL-ECT. Efficacy was measured by a ≥30% reduction in symptom severity on the PANSS scale and overall improvement measured with the Clinical Global Impression scale. Cognitive function was assessed with the Montreal Cognitive Assessment (MoCA) and Brief Assessment of Cognition in Schizophrenia (BACS) scales.
Read the detailed description
Study Design and Setting: Randomized experimental trial at Fray Bernardino Álvarez Psychiatric Hospital, Mexico City.
Sample Size: Quota sampling. Eligibility Criteria: inpatients, spanish-speaking, ≥18 years old with DSM-5 schizophrenia diagnosis, PANSS total score ≥60, and treatment with 1-2 antipsychotics (including clozapine). Exclusions: ECT within 3 months, affective comorbidities, catatonia, pregnancy, anesthesia/ECT contraindications, or incomplete follow-up.
Equipment and Technique: Pre-ECT evaluations included ECG, chest X-ray, blood tests, and assessments by internists/anesthesiologists. ECT was administered by a principal investigator (Emory University-certified) using a MECTA Corp spECTrum 5000Q device, 3x/week (excluding weekends). Electrode placement: bitemporal (BT) with brief pulses (≥0.5 ms) or right unilateral (RUL; D'Elia placement) with ultrabrief pulses (≤0.3 ms). Initial titration doses: 48 mC (BT) or 4.8 mC (RUL), doubled until adequate seizure (assessed via Clinical and Seizure Based Stimulation method). Maintenance doses: 2x threshold (BT) or 6x threshold (RUL), adjusted by 50% for poor-quality seizures. Premedication: atropine (1 mg IM), propofol (1 mg/kg IV), and succinylcholine (1 mg/kg IV).
Intervention and Comparator: Active comparator: BT-ECT vs. RUL-ECT.(intervention) No placebo group due to institutional constraints.
Randomization and Blinding: Block randomization (Microsoft Excel-generated) by an independent researcher. Allocation sequence concealed by an assistant and disclosed pre-treatment.
Outcomes: Efficacy: ≥30% PANSS reduction; Safety: Adverse event frequency/severity/time to adverse event onset. Cognition: MoCA and BACS pre-/post-ECT (administered by neuropsychology-trained staff).
Ethics: Conducted per WMA Declaration of Helsinki. Informed consent obtained from patients' legal guardians due to severe mental impairment in participants
- Conditions
- Schizophrenia Disorders
- Being tested
- Ultrabrief pulse electroconvulsive therapy, Brief pulse Electroconvulsive therapy
- Keywords
- Electroconvulsive teraphy, Schizophrenia, Rigth unilateral, Cognition, Efficacy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrabrief pulse electroconvulsive therapyProcedure or surgery
Therapeutic seizure induction with pulse unidirectional electric charge through the right hemisphere, using ultrabrief pulses (≤0.3 ms).
Brief pulse Electroconvulsive therapyProcedure or surgery
Therapeutic seizure induction with pulse unidirectional electric charge through the temporal hemisferes, using brief pulses (≥0.5 ms).
| Study group | Role | What they receive |
|---|---|---|
| Rigth unilateral electrode placement | Experimental | Anode (Right Temporal): Centered over the right temporal lobe, 2.5 cm (1 inch) above the midpoint of an imaginary line connecting the tragus and the external canthus.
Cathode (Right Parietal): Placed vertically 10 cm (4 inches) above the temporal electrode, aligned with the parietal bone (midline between the temporal and occipital regions). Receives: Procedure: Ultrabrief pulse electroconvulsive therapy |
| Bitemporal electrode placement | Active comparator | Anode placed over the left temporal region: Positioned 2.5 cm (1 inch) above the midpoint of an imaginary line connecting the tragus (ear canal) and the external canthus (outer corner) of the left eye.
Catode positioned over the right temporal region: Mirror placement on the right side, symmetrically aligned with the left electrode. Receives: Procedure: Brief pulse Electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of electroconvulsive therapy technique
Treatment response is defined as a ≥20% reduction in the total score of the Positive and Negative Syndrome Scale (PANSS) after treatment. A dichotomous classification was applied (responders vs. non-responders) The PANSS assesses symptom severity through 30 items, each scored on a 1-7 scale, where: 1 = Absent (no symptom) and 7 = Extreme (severe symptom). Higher PANSS scores indicate greater symptom severity, meaning a lower score reflects a better clinical outcome.
Measured: 48 hours after last ECT session
Secondary outcomes (4)
Adverse effect incidence
The incidence of side effects will be expressed as the percentage of subjects affected within each study group.
Measured: Between two hours and 24 hours after the last ECT session
Time to adverse event onset measured in number of sessions
Time to adverse event onset is defined as the number of completed ECT sessions where the outcome is first documented. Count of sessions from Session 1 (baseline) to the session where the AE is first documented.
Measured: From the first session until 48 hours after last session
Cognitive changes measured by MoCA
Change in total Montreal Cognitive Assessment (MoCA) score at the end of treatment. Result will be analyzed as a continuous linear variable.
MoCA evaluates 7 domains, with item-level binary scoring (0/1). Serial-7s allow up to 3 points (1 per correct subtraction). Total scores are interpreted against validated cutoffs. Cutoff: <26/30 suggests impairment (adjusted for education ≤12 years: +1 point). Total Score: 0-30 (higher = better cognition).
Measured: 48 hours after last ECT session
Cognitive changes measured by BACS
Change in Brief Assessment of Cognition in Schizophrenia (BACS) total score post-treatment.
BACS is a neuropsychological battery designed to assess cognitive impairment in individuals with schizophrenia. Consists of 6 subtests, each assessing a specific cognitive domain. Raw scores are converted to standardized z-scores (mean = 0, SD = 1) based on normative data. Higher scores = Better cognitive performance.
Measured: 48 hours after last ECT session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start16 Mar 2023
- Primary completion16 Oct 2024
- Study completion16 Nov 2024
Why it stopped: Change in operative and administrative functions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia DisordersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Psiquiátrico Fray Bernardino Álvarez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Héctor Octavio Castañeda González, Hospital Psiquiátrico Fray Bernardino Álvarez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972745
- Sponsor's protocol ID
- CI-962
- Acronym
- ULTEC
- Status last verified
- May 2025
- First submitted
- 20 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Castaneda-Gonzalez HO, Magana-Ornelas A, Santiago-Maury AR, Lopez SS, Leonor-Hernandez IJ, Cabello-Rangel H. Electroconvulsive Therapy in Schizophrenia: Exploratory Study on the Efficacy, Cognitive Effects, and Safety of Right Unilateral Versus Bitemporal Techniques. Brain Behav. 2026 Apr;16(4):e71351. doi: 10.1002/brb3.71351.
PubMed 41888071
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Efficacy and Tolerance of Right Unilateral Electroconvulsive Therapy vs. Bitemporal in Patients With Paranoid Schizophrenia in Acute Psychosis at Fray Bernardino Álvarez Psychiatric Hospital
- ClinicalTrials.gov ID
- NCT06972745
- Acronym / sponsor ID
- ULTEC / CI-962
- Conditions
- Schizophrenia Disorders
- Keywords
- Electroconvulsive teraphy, Schizophrenia, Rigth unilateral, Cognition, Efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in operative and administrative functions
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hospital Psiquiátrico Fray Bernardino ÁlvarezUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Nov 2024 (actual)
- First posted
- 15 May 2025 (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.
Electroconvulsive therapy (ECT) is an established treatment for medication-resistant schizophrenia. There is debate about the best method of electrode placement. Bitemporal (BT) placement is commonly used for schizophrenia, while right unilateral (RUL) placement in mood disorders is associated with fewer adverse effects on memory and language. This study compares the efficacy, safety and cognitive effects of BT-ECT versus RUL-ECT in hospitalized schizophrenia patients with acute psychosis.
Main Question: Does RUL-ECT reduce psychotic symptoms with fewer cognitive effects versus BT-ECT in patients with severe schizophrenia? Hypothesis: RUL-ECT is as effective as BT-ECT in reducing psychotic symptoms with fewer cognitive effects.
Methods: Randomized trial in patients with schizophrenia (confirmed by DSM 5 criteria) and severe symptoms (PANSS score ≥60). Patients were assigned to receive BT-ECT or RUL-ECT. Efficacy was measured by a ≥30% reduction in symptom severity on the PANSS scale and overall improvement measured with the Clinical Global Impression scale. Cognitive function was assessed with the Montreal Cognitive Assessment (MoCA) and Brief Assessment of Cognition in Schizophrenia (BACS) scales.
Detailed description
Study Design and Setting: Randomized experimental trial at Fray Bernardino Álvarez Psychiatric Hospital, Mexico City.
Sample Size: Quota sampling. Eligibility Criteria: inpatients, spanish-speaking, ≥18 years old with DSM-5 schizophrenia diagnosis, PANSS total score ≥60, and treatment with 1-2 antipsychotics (including clozapine). Exclusions: ECT within 3 months, affective comorbidities, catatonia, pregnancy, anesthesia/ECT contraindications, or incomplete follow-up.
Equipment and Technique: Pre-ECT evaluations included ECG, chest X-ray, blood tests, and assessments by internists/anesthesiologists. ECT was administered by a principal investigator (Emory University-certified) using a MECTA Corp spECTrum 5000Q device, 3x/week (excluding weekends). Electrode placement: bitemporal (BT) with brief pulses (≥0.5 ms) or right unilateral (RUL; D'Elia placement) with ultrabrief pulses (≤0.3 ms). Initial titration doses: 48 mC (BT) or 4.8 mC (RUL), doubled until adequate seizure (assessed via Clinical and Seizure Based Stimulation method). Maintenance doses: 2x threshold (BT) or 6x threshold (RUL), adjusted by 50% for poor-quality seizures. Premedication: atropine (1 mg IM), propofol (1 mg/kg IV), and succinylcholine (1 mg/kg IV).
Intervention and Comparator: Active comparator: BT-ECT vs. RUL-ECT.(intervention) No placebo group due to institutional constraints.
Randomization and Blinding: Block randomization (Microsoft Excel-generated) by an independent researcher. Allocation sequence concealed by an assistant and disclosed pre-treatment.
Outcomes: Efficacy: ≥30% PANSS reduction; Safety: Adverse event frequency/severity/time to adverse event onset. Cognition: MoCA and BACS pre-/post-ECT (administered by neuropsychology-trained staff).
Ethics: Conducted per WMA Declaration of Helsinki. Informed consent obtained from patients' legal guardians due to severe mental impairment in participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rigth unilateral electrode placement | Experimental | Procedure: Ultrabrief pulse electroconvulsive therapyAnode (Right Temporal): Centered over the right temporal lobe, 2.5 cm (1 inch) above the midpoint of an imaginary line connecting the tragus and the external canthus. Cathode (Right Parietal): Placed vertically 10 cm (4 inches) above the temporal electrode, aligned with the parietal bone (midline between the temporal and occipital regions). |
| Bitemporal electrode placement | Active comparator | Procedure: Brief pulse Electroconvulsive therapyAnode placed over the left temporal region: Positioned 2.5 cm (1 inch) above the midpoint of an imaginary line connecting the tragus (ear canal) and the external canthus (outer corner) of the left eye. Catode positioned over the right temporal region: Mirror placement on the right side, symmetrically aligned with the left electrode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Ultrabrief pulse electroconvulsive therapyTherapeutic seizure induction with pulse unidirectional electric charge through the right hemisphere, using ultrabrief pulses (≤0.3 ms). | Procedure or surgery | Rigth unilateral electrode placement |
| Brief pulse Electroconvulsive therapyTherapeutic seizure induction with pulse unidirectional electric charge through the temporal hemisferes, using brief pulses (≥0.5 ms). | Procedure or surgery | Bitemporal electrode placement |
Primary outcome
Efficacy of electroconvulsive therapy technique
Time frame: 48 hours after last ECT session
Treatment response is defined as a ≥20% reduction in the total score of the Positive and Negative Syndrome Scale (PANSS) after treatment. A dichotomous classification was applied (responders vs. non-responders) The PANSS assesses symptom severity through 30 items, each scored on a 1-7 scale, where: 1 = Absent (no symptom) and 7 = Extreme (severe symptom). Higher PANSS scores indicate greater symptom severity, meaning a lower score reflects a better clinical outcome.
4 secondary outcomes
Adverse effect incidence
Time frame: Between two hours and 24 hours after the last ECT session
Time to adverse event onset measured in number of sessions
Time frame: From the first session until 48 hours after last session
Cognitive changes measured by MoCA
Time frame: 48 hours after last ECT session
Cognitive changes measured by BACS
Time frame: 48 hours after last ECT session
Results and safety
The study was stopped early (reason given: Change in operative and administrative functions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 41888071Castaneda-Gonzalez HO, Magana-Ornelas A, Santiago-Maury AR, Lopez SS, Leonor-Hernandez IJ, Cabello-Rangel H. Electroconvulsive Therapy in Schizophrenia: Exploratory Study on the Efficacy, Cognitive Effects, and Safety of Right Unilateral Versus Bitemporal Techniques. Brain Behav. 2026 Apr;16(4):e71351. doi: 10.1002/brb3.71351.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrabrief pulse electroconvulsive therapy and Brief pulse Electroconvulsive therapy in people with Schizophrenia Disorders, run by Hospital Psiquiátrico Fray Bernardino Álvarez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 May 2025. 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 Mexico. 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. 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: Change in operative and administrative functions). 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?
Efficacy of electroconvulsive therapy technique (time frame: 48 hours after last ECT session). 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 NCT06972745, which also lists 1 linked publication.
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 15 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.