Niacin skin flushing response in evaluating the efficacy of modified electroconvulsive therapy in schizophrenia
| ISRCTN | ISRCTN12245577 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12245577 |
- Submission date
- 09/02/2025
- Registration date
- 18/02/2025
- Last edited
- 10/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Schizophrenia is a group of chronic neurodevelopmental disorders. Drug therapy is the main treatment. Modified electroconvulsive therapy (MECT) is also considered an effective treatment method. The aim of this study was to explore the clinical characteristics of patients undergoing MECT treatment, including positive, negative, and general psychotic symptoms, and the improvement of these characteristics after treatment.
Who can participate?
Patients with schizophrenia aged 18-65 years who are registered at the Fourth People's Hospital of Wuhu
What does the study involve?
In this non-randomized study, a total of 70 hospitalized patients with schizophrenia underwent eligibility assessment. Participants were divided into two groups based on whether they met the criteria for treatment-resistant schizophrenia (TRS). Among the 40 patients with TRS, eight declined to undergo MECT. The remaining consenting patients received a 6-week course of MECT combined with antipsychotic medication (SZ-MECT group). Among the 30 patients with non-treatment-resistant schizophrenia (N-TRS), all patients agreed to participate in the study and underwent 6 weeks of antipsychotic medication treatment (SZ-N group).
What are the possible benefits and risks of participating?
Participants who receive the free treatment may benefit from a reduction in their depressive symptoms. There are no known risks involved with participating.
Where is the study run from?
The Fourth People's Hospital of Wuhu (China)
When is the study starting and how long is it expected to run for?
December 2022 to December 2025
Who is funding the study?
1. Health Commission of Anhui Province (China)
2. Department of Science and Technology of Anhui Province (China)
Who is the main contact?
Bingbing Sui, 19956720391@163.com
Contact information
Principal Investigator
Wuxiashan East Road
Wuhu
241000
China
| 3081586616@qq.com |
Public, Scientific
Wuxiashan East Road
Wuhu
241000
China
| 19956720391@163.com |
Study information
| Study design | Single-centre interventional non-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Treatment, Efficacy |
| Scientific title | Changes in psychiatric symptoms and niacin skin flushing response after modified electroconvulsive therapy, and the correlation between them in schizophrenia |
| Study acronym | NSFR SZ |
| Study objectives | Current interventions as of 10/03/2025: The primary aim of this study was to compare the clinical characteristics of patients with treatment-resistant schizophrenia (TRS) and non-treatment-resistant schizophrenia (N-TRS), including the severity of clinical symptoms and the niacin skin flushing response (NSFR), which is considered an auxiliary diagnostic biomarker for schizophrenia (SZ), and investigate the relationship between NSFR and the severity of symptoms. Additionally, this study also investigated whether the patients with TRS could achieve comparable clinical remission through modified electroconvulsive therapy (MECT) to that of the patients with N-TRS receiving conventional antipsychotic drugs, to provide further evidence in support of the efficacy of MECT in the treatment of SZ. Previous interventions: The aim of this study is to evaluate the relationship between the efficacy of modified electroconvulsive therapy and niacin skin flushing response in schizophrenia, and explore whether niacin skin flushing response is related to psychiatric symptoms. |
| Ethics approval(s) |
Approved 29/12/2023, Ethical Committee of the Fourth People's Hospital of Wuhu (The Fourth People's Hospital of Wuhu, Wuhu, 241000, China; -; whsyllwyh@163.com), ref: [2023]-KY-052 |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | Current interventions as of 10/03/2025: Participants were divided into two groups based on whether they met the criteria for treatment-resistant schizophrenia (TRS). Among the 40 patients with TRS, 8 declined to undergo MECT. The remaining consenting patients received a 6-week course of MECT combined with antipsychotic medication (SZ-MECT group, n = 32). Among the 30 patients with non-treatment-resistant schizophrenia (N-TRS), all patients agreed to participate in the study and underwent 6 weeks of antipsychotic medication treatment (SZ-N group, n = 30). The drugs include chlorpromazine, aripiprazole, olanzapine, and risperidone (appropriate dosage and frequency of medication based on the patient's condition). The MECT frequency is 2-3 times a week, adjusted according to the patient's condition. Previous interventions: The study recruited a total of 62 patients with schizophrenia. 30 schizophrenia individuals took only anti-psychotics (SZ-N group) and 32 schizophrenia patients received MECT combined with anti-psychotics (SZ-MECT group). The research group combined MECT with antipsychotic drug treatment. The drugs include chlorpromazine, aripiprazole, olanzapine, and risperidone (appropriate dosage and frequency of medication based on the patient's condition). The MECT frequency is 2-3 times a week, adjusted according to the patient's condition. The follow-up time was at baseline, week 2, week 4, and week 6. The total treatment time is adjusted according to the patient's symptoms. The control group was only treated with antipsychotic drugs, including clozapine, aripiprazole, olanzapine, and risperidone (appropriate dosage and frequency of medication based on the patient's condition). All patients underwent Positive and Negative Syndrome Scale (PANSS) and niacin skin flushing response (NSFR) scores at baseline (t1) and follow-up (t2, ~4 weeks) time points. Group differences in changes of the NSFR between two schizophrenia groups over time, as well as the correlation between psychiatric symptoms and niacin skin flushing response, were assessed. |
| Intervention type | Mixed |
| Primary outcome measure | Psychiatric symptoms measured using the Positive and Negative Syndrome Scale (PANSS) at baseline, weeks 2, 4, and 6. |
| Secondary outcome measures | Niacin skin flushing response test using 6 different concentrations (triple gradient dilution from 60 mM) of niacin dropped onto the skin at baseline, week 2, 4, and 6 |
| Overall study start date | 31/12/2022 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 62 |
| Key inclusion criteria | 1. Patients diagnosed according to the ICD10 (International Classification of Diseases, 10th Revision) criteria for SZ 2. 18 to 65 years old 3. PANSS score was within the range of 70~120 |
| Key exclusion criteria | 1. Severe neurological diseases or traumatic brain injury or substance dependence 2. Administration of non-steroidal or steroidal anti-inflammatory drugs within 2 weeks 3. MECT administration 1 month before admission 4. MECT contraindications (including anesthesia allergy, intracranial space-occupying lesions, active pulmonary inflammation, recent myocardial infarction, recent cerebral hemorrhage, retinal detachment, untreated glaucoma, etc) 5. Pregnancy |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Wuhu
241000
China
Sponsor information
Hospital/treatment centre
Wuxiashan East Road
Wuhu
241000
China
| Phone | +86 (0)13909635287 |
|---|---|
| songchfu@163.com |
Funders
Funder type
Government
No information available
Government organisation / Local government
- Alternative name(s)
- Anhui Department of Science and Technology, 安徽省科学技术厅, Department of Science and Technology of Anhui Province
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Bingbing Sui (19956720391@163.com) |
Editorial Notes
10/03/2025: The study hypothesis and interventions were updated. The target number of participants was changed from 62 to 70. Total final enrolment added.
11/02/2025: Study's existence confirmed by Beijing Anding Hospital.
