SchizophreniaPhase 2NCT04518319
Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome
A Phase 2 study testing Omega-3 polyunsaturated fatty acids, Xbox aerobic exercise and transcranial direct current stimulation,tDCS in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This is a single-center, randomized, parallel-control study conducted in schizophrenic inpatients with metabolic syndrome who have been conducted with olanzapine. The purpose of this study is to evaluate the efficacy and safety of omega-3 polyunsaturated fatty acids, Xbox aerobic exercise and transcranial direct… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Omega-3 polyunsaturated fatty acids, Xbox aerobic exercise and transcranial direct current stimulation,tDCS
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to Nov 2024
- Phase
- Phase 2
- 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
- Meets the Diagnostic and Statistical Manual of Mental Disorder,Fifth Edition(DSM-V) criteria for Schizophrenia.
- Patients have got standard treatment of olanzapine monotherapy for more than 6 months, PANSS baseline ≤ 60.
- Meets the ATP-III criteria for metabolic syndrome.
- Male or female subjects aged 18-60 years, education level of junior high school for above.
- The patient fully understand and signed the informed consent form.
Who cannot join
- Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
- Pregnant or lactating women and women of childbearing potential throughout the study period; patients who have plans to move to other places within the year.
- History of diabetes, hyperlipidemia and other metabolic abnormalities.
- Due to other reasons, the researchers considered it unsuitable to participate in this clinical trial.
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome
This is a single-center, randomized, parallel-control study conducted in schizophrenic inpatients with metabolic syndrome who have been conducted with olanzapine. The purpose of this study is to evaluate the efficacy and safety of omega-3 polyunsaturated fatty acids, Xbox aerobic exercise and transcranial direct current stimulation( tDCS). Following a screening period, subjects who meet the entry criteria will be randomized to treated with omega-3 polyunsaturated fatty acids1.2mg per day, Xbox aerobic exercise 30min per day and tDCS at 2mA, 20 min(5 session/week) for 12 weeks.
- Conditions
- Schizophrenia
- Being tested
- Omega-3 polyunsaturated fatty acids, Xbox aerobic exercise, transcranial direct current stimulation,tDCS, Olanzapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 polyunsaturated fatty acidsDrug
Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine.
Xbox aerobic exerciseBehavioural
Patients will do Xbox aerobic exercise 30min per day plus on olanzapine.
transcranial direct current stimulation,tDCSDevice
Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine.
OlanzapineDrug
Patients will take only olanzapine pills.
| Study group | Role | What they receive |
|---|---|---|
| omega-3 polyunsaturated fatty acids | Experimental | Patients randomized to the omega-3 polyunsaturated fatty acids will receive treatment with 1200mg per day plus on-going olanzapine. Receives: Drug: Omega-3 polyunsaturated fatty acids |
| Xbox aerobic exercise | Experimental | Patients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine. Receives: Behavioral: Xbox aerobic exercise |
| transcranial direct current stimulation | Experimental | Patients randomized to the transcranial direct current stimulation will be applied for transcranial direct current stimulation 5 session/week at 2mA, 20min plus on-going olanzapine. The anodal electrode will be placed over the left dorsolateral prefrontal cortex. Receives: Device: transcranial direct current stimulation,tDCS |
| olanzapine | Experimental | Patients randomized to the olanzapine will receive conventional treatment-olanzapine. Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome
Change in the the MATRICS consensus cognitive battery between randomization
Measured: from baseline to 3 months after treatment
Secondary outcomes (7)
change in the Schizophrenia Quality of Life Scale(SQLS)
The aim is to explore what kind of intervention will improve the quality of life as measured with the Schizophrenia Quality of Life Scale(SQLS). The scores between 1-100. The lower scores means a better outcome.
Measured: assessed from baseline to 3 months after treatment
change in the scale of social function in psychosis inpatients
The aim is to explore what kind of intervention will improve the patients' social function as measured with the scale of social function in psychosis inpatients(SSPI).<18 points means severe defects, 18-28 points means moderate defects, 29-38 means mild defects. The higher scores means a better outcome.
Measured: assessed from baseline to 3 months after treatment
metabolic indicators
Height(kilograms) and weight(meters) will be measured to evaluate the patients' BMI(kg/m2) at baseline, week4,12,16(1months after treatment ) and 24(3 months after treatment).
Measured: assessed from baseline to week 24
biological index
CRP(mg/dl) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
Measured: assessed from baseline to week 24
biological index
C3（g/l）will be tested to determine whether the interventions measures will affect the inflammatory biomarkers
Measured: assessed from baseline to week 24
biological index
IL-6(U/L) will be tested to determine whether the interventions measures will affect the inflammatory biomarkers.
Measured: assessed from baseline to week 24
biological index
brain-derived neurotrophic factor( BDNF) will be tested to determine whether the interventions measures will affect the BDNF.
Measured: assessed from baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Oct 2020
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: The COVID-19 affects the recruitment of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan CHEN, Shanghai Mental Health Center
- Investigators
- Yan Chen, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518319
- Sponsor's protocol ID
- 20200815SMHC-sk-YChen
- Status last verified
- Apr 2023
- First submitted
- 13 Aug 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comprehensive Intervention on Cognitive Impairment of Schizophrenia Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04518319
- Acronym / sponsor ID
- 20200815SMHC-sk-YChen
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The COVID-19 affects the recruitment of patients.
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 19 Aug 2020 (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.
This is a single-center, randomized, parallel-control study conducted in schizophrenic inpatients with metabolic syndrome who have been conducted with olanzapine. The purpose of this study is to evaluate the efficacy and safety of omega-3 polyunsaturated fatty acids, Xbox aerobic exercise and transcranial direct current stimulation( tDCS). Following a screening period, subjects who meet the entry criteria will be randomized to treated with omega-3 polyunsaturated fatty acids1.2mg per day, Xbox aerobic exercise 30min per day and tDCS at 2mA, 20 min(5 session/week) for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| omega-3 polyunsaturated fatty acids | Experimental | Drug: Omega-3 polyunsaturated fatty acidsPatients randomized to the omega-3 polyunsaturated fatty acids will receive treatment with 1200mg per day plus on-going olanzapine. |
| Xbox aerobic exercise | Experimental | Behavioral: Xbox aerobic exercisePatients randomized to the Xbox aerobic exercise will do Xbox aerobic exercise 30min per day plus on-going olanzapine. |
| transcranial direct current stimulation | Experimental | Device: transcranial direct current stimulation,tDCSPatients randomized to the transcranial direct current stimulation will be applied for transcranial direct current stimulation 5 session/week at 2mA, 20min plus on-going olanzapine. The anodal electrode will be placed over the left dorsolateral prefrontal cortex. |
| olanzapine | Experimental | Drug: OlanzapinePatients randomized to the olanzapine will receive conventional treatment-olanzapine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Meets the Diagnostic and Statistical Manual of Mental Disorder,Fifth Edition(DSM-V) criteria for Schizophrenia.
- Patients have got standard treatment of olanzapine monotherapy for more than 6 months, PANSS baseline ≤ 60.
- Meets the ATP-III criteria for metabolic syndrome.
- Male or female subjects aged 18-60 years, education level of junior high school for above.
- The patient fully understand and signed the informed consent form.
Key exclusion criteria (5 listed)
- Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
- Pregnant or lactating women and women of childbearing potential throughout the study period; patients who have plans to move to other places within the year.
- History of diabetes, hyperlipidemia and other metabolic abnormalities.
- Due to other reasons, the researchers considered it unsuitable to participate in this clinical trial.
- -
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 |
|---|---|---|
| Omega-3 polyunsaturated fatty acidsOmega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine. | Drug | omega-3 polyunsaturated fatty acids |
| Xbox aerobic exercisePatients will do Xbox aerobic exercise 30min per day plus on olanzapine. | Behavioural | Xbox aerobic exercise |
| transcranial direct current stimulation,tDCSPatients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine. | Device | transcranial direct current stimulation |
| OlanzapinePatients will take only olanzapine pills. | Drug | olanzapine |
Primary outcome
Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome
Time frame: from baseline to 3 months after treatment
Change in the the MATRICS consensus cognitive battery between randomization
7 secondary outcomes
change in the Schizophrenia Quality of Life Scale(SQLS)
Time frame: assessed from baseline to 3 months after treatment
change in the scale of social function in psychosis inpatients
Time frame: assessed from baseline to 3 months after treatment
metabolic indicators
Time frame: assessed from baseline to week 24
biological index
Time frame: assessed from baseline to week 24
biological index
Time frame: assessed from baseline to week 24
biological index
Time frame: assessed from baseline to week 24
biological index
Time frame: assessed from baseline to week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
Yan Chen principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 polyunsaturated fatty acids, Xbox aerobic exercise and transcranial direct current stimulation,tDCS in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
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 5 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: paused, as of the sponsor's last update on 18 Apr 2023. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Explore the treatment of cognitive impairment in schizophrenia patients with metabolic syndrome (time frame: from baseline to 3 months after treatment). 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 18 Apr 2023.