A study on the therapeutic effect of modified electroconvulsive therapy in refractory schizophrenia
| ISRCTN | ISRCTN96331501 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96331501 |
- Submission date
- 27/02/2024
- Registration date
- 11/03/2024
- Last edited
- 08/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Treatment-resistant schizophrenia (TRS) tends to be protracted and difficult to cure. Commonly used prescription drugs include clozapine and risperidone, which can effectively alleviate the positive symptoms of patients. Long-term medication will inevitably affect the immune function of patients and may bring some side effects. Modified electroconvulsive therapy (MECT), which applies a short, moderate current to the brain, induces a brief state of unconsciousness and improves mental state. There is limited research on the combination of MECT with risperidone and psychotherapy in TRS. Therefore, this study aims to explore the effectiveness of MECT combined with risperidone and psychotherapy in improving the mood and symptoms of patients with TRS.
Who can participate?
Patients aged over 18 years old who have had TRS for over 5 years and have had previous treatment with two or more antipsychotic drugs of different chemical structures, each at a sufficient dosage, with no significant improvement after continuous treatment for more than 2 months
What does the study involve?
Participants were randomly divided into a control group and a study group, with the control group receiving risperidone tablets and psychotherapy, and the study group undergoing MECT as well as the control group treatment. The treatment lasted for 2 months.
What are the possible benefits and risks of participating?
Participants may get better results from the new treatments. Participants' immune function may also be affected by long-term medications, which are routine therapeutic drugs for TRS.
Where is the study run from?
Wuhan Wudong Hospital (China)
When is the study starting and how long is it expected to run for?
July 2017 to March 2020
Who is funding the study?
Wuhan Municipal Health Commission (China)
Who is the main contact?
Qiu-Ming Ji, jiqiuming79@163.com
Contact information
Public, Scientific, Principal Investigator
No. 46 of Wudong Street
Qingshan District
Wuhan
430084
China
| Phone | +86 (0)27 5052 8367 |
|---|---|
| jiqiuming79@163.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Efficacy of modified electroconvulsive therapy in treatment-resistant schizophrenia |
| Study objectives | To explore the efficacy of combining modified electroconvulsive therapy (MECT) with risperidone and psychotherapy in improving the emotions and symptoms of patients with treatment-resistant schizophrenia (TRS). |
| Ethics approval(s) |
Approved 30/12/2017, Wuhan Wudong Hospital (No. 46 of Wudong Street, Qingshan District, Wuhan , 430084, China; +86 (0)27 50528367; 281970698@qq.com), ref: WDYY-LL-2017-12 |
| Health condition(s) or problem(s) studied | Treatment-resistant schizophrenia |
| Intervention | Participants were randomly divided into a control group and a study group, with the control group receiving risperidone tablets and psychotherapy, and the study group undergoing MECT as well as the control group treatment. The control group took risperidone tablets orally. The daily dose was 1 mg at the beginning of medication, and the medication was continued for 7 days. Subsequently, the dose is gradually increased to 4~6 mg per day. According to the patient's individual situation, the drug dosage was adjusted as needed to ensure that the maximum daily dose was less than 6 mg. Psychotherapists assessed the patients' mental status every week during their hospitalization and actively provided positive psychotherapy and guidance. The treatment lasted for 2 months. The study group received MECT treatment on the basis of the control group. MECT treatment is performed three times a week, and the frequency is gradually reduced according to the specific conditions of patients. A course of treatment includes about 8~12 courses, which last for about 2 months. Risperidone tablets (Xi’an Janssen Pharmaceutical Ltd., Xi'an, China; Chinese Pharmacopoeia Registration Number H20010309) The Thymatron® System IV (America) 1 mg of atropine (Wuhu Kangqi Pharmaceutical Co., Ltd., Wuhu China; Chinese Pharmacopoeia Registration Number H34021900) 1.5 mg/kg propofol (Guangdong Jiabo Pharmaceutical Co., Ltd., Guangdong China; Chinese Pharmacopoeia Registration Number H20051843) 1–1.5 mg/kg of succinylcholine chloride (Shanghai Xudong Haipu Pharmaceutical Co., Ltd., Shanghai China; Chinese Pharmacopoeia Registration Number H31020599) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Risperidone, Thymatron® System IV, atropine, propofol, succinylcholine chloride |
| Primary outcome measure | Severity of positive and negative symptoms assessed using the Positive and Negative Syndrome Scale (PANSS) at baseline and 2 months after treatment |
| Secondary outcome measures | Measured before treatment and 2 months after treatment: 1. Anxiety and depression measured using the Hamilton Anxiety Rating Scale (HAMA) and the Hamilton Depression Rating Scale (HAMD) 2. Severity of trauma exposure measured using the Traumatic Exposure Severity Scale (TESS) 3. Severity of disease measured using the Brief Psychiatric Rating Scale (BPRS) 4. Memory measured using the Wechsler Memory Scale (WMS) |
| Overall study start date | 01/07/2017 |
| Completion date | 01/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 108 |
| Total final enrolment | 108 |
| Key inclusion criteria | 1. Aged >18 years old 2. With complete medical records 3. With Positive and Negative Syndrome Scale (PANSS) scores for both positive and negative symptoms >60 points 4. With a clinical diagnosis of TRS 5. Who had had TRS for >5 years 6. Who had had previous treatment with 2 or more antipsychotic drugs of different chemical structure, each at a sufficient dosage, with no significant improvement after continuous treatment for more than 2 months 7. Those who did not show drug intolerance or maladaptation during the course of this study |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- China
Study participating centre
Qingshan District
Wuhan
430084
China
Sponsor information
Hospital/treatment centre
No. 46 of Wudong Street
Qingshan District
Wuhan
430084
China
| Phone | +86 (0)27 86438247 |
|---|---|
| jiqiuming79@163.com | |
| Website | http://www.wdyy.com/ |
"ROR" |
https://ror.org/00qtzg544 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 12/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
06/03/2024: Study's existence confirmed by Wuhan Wudong Hospital.
