SchizophreniaNCT04055181

Influence of rTMS on Symptoms and Cognitive Function in Patients With Psychiatric Disorders

A study testing rTMS in schizophrenia patients and rTMS in major depressive disorders patients in people with Schizophrenia and Major Depressive Disorder, run by Beijing HuiLongGuan Hospital at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The investigators investigated the effects of high frequency (10Hz) repetitive transcranial magnetic stimulation (rTMS) on the symptoms and cognitive functioning in patients with psychiatric disorders Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Schizophrenia, Major Depressive Disorder
What is being tested?: rTMS in schizophrenia patients and rTMS in major depressive disorders patients
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 800 participants
Where: 6 sitesChina
Study dates: 1 Dec 2018to 30 Jan 2020
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

For Schizophrenia Patients:
Diagnosis of schizophrenia by two senior psychiatrists
Between 18 and 60 years and Han Chinese
Duration of symptoms at least 12 months
With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS < 24)
Smoking

Show all 11Show fewer

For Major Depressive Disorder Patients:
Diagnosis of Major depressive disorder by two senior psychiatrists
Between 18 and 60 years and Han Chinese
Duration of symptoms at least 12 months
Smoking

Who cannot join

Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
Severe headache for unknown reasons and cardiovascular diseases, intracranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months
Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures
Education level less than 5 years by subject report
Receiving or planning to start the psychotherapy during the rTMS treatment or past received psychotherapy 6 months before the current study
Subjects who suffered from alcohol or illegal drug abuse/dependence

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Chaohu Hospital of Anhui medical unviersity
Chaohu, Anhui, 238000
Ganzhou Third Hospital
Ganzhou, Jiangxi, 341000
Ningxia Mental Health Center
Ning’an, Ningxia, 755100
Wuhan Mental Health Center
Wuhan, Hubei, 100096
Xi'an Mental Health Center
Xi’an, Shanxi, 710000
Zhongshan Third People's Hospital
Zhongshan, Guangdong, 528400

Other trials in China

About this study

Official title: Influence of rTMS on Symptoms and Cognition in Patients With Psychiatric Disorders

Read the detailed description

OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency rTMS over left dorsolateral prefrontal cortex in the treatment of symptoms and cognitive functioning in 200 chronic patients with schizophrenia and 200 patients with major depressive disorders

METHODS:

Clinical Trial：The study consists of 4 weeks of treatment.
Assess Procedures:

2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the Positive and Negative Syndrome Scale (PANSS) or DSM-IV for depression, and repeatable battery for the assessment of neuropsychological status(RBANS).Patients are interviewed at screening, at at baseline, 4 weeks, 16 weeks.

2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at baseline, 4 weeks, and 16 weeks.

2.3 Weight gain measurement: weight gain every week

Conditions: Schizophrenia, Major Depressive Disorder
Being tested: rTMS in schizophrenia Controls, rTMS in schizophrenia patients, rTMS in major depressive disorders controls, rTMS in major depressive disorders patients
Keywords: schizophrenia, smoking, rTMS, major depressive disorder
Medical subject headings: Schizophrenia, Depressive Disorder, Major, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rTMS in schizophrenia ControlsDevice
all procedures were identical to "rTMS in schizophrenia patients" group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
rTMS in schizophrenia patientsDevice
10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks
rTMS in major depressive disorders controlsDevice
all procedures were identical to "rTMS in major depressive disorders patients" group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
rTMS in major depressive disorders patientsDevice
10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks

Study groups in NCT04055181
Study group	Role	What they receive
rTMS in schizophrenia patients	Active comparator	In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks Receives: Device: rTMS in schizophrenia patients
rTMS in schizophrenia Controls	Sham comparator	In sham rTMS, all procedures were identical to 10Hz Schizophrenia group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated. Receives: Device: rTMS in schizophrenia Controls
rTMS in major depressive disorders patients	Active comparator	In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks Receives: Device: rTMS in major depressive disorders patients
rTMS in major depressive disorders controls	Sham comparator	In sham rTMS, all procedures were identical to 10Hz depression group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated. Receives: Device: rTMS in major depressive disorders controls

What is being measured

The primary outcome is the main question the study is designed to answer.

symptoms assessed on PANSS
The Positive and Negative Syndrome Scale is often shorted as PANSS. It is a well-characterized and well-applied measurement instrument that measures positive and negative syndromes, their differential and general severity of illness. The items on the PANSS are defined with increasing levels from 1 to 7, the greater the value appears, the severe the level is: 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate-severe, 6 = severe, and 7 = extreme. The PANSS score is finalized by summation of ratings across different items, the potential range for positive and negative scales are from 7 to 49 whereas the General Psychopathology Scale is ranged between 16 to 112.
Measured: 4 weeks
cognitive functioning assessed on RBANS
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a test for identifying and characterizing abnormal cognitive decline in the elders and examining neuropsychological disorders for younger adults. The RBANS is comprised of five domains, which are Immediate Memory, Visuospatial /Constructional, Language, Attention and Delayed Memory. Each of the five index is based on two subtests except Delayed memory index consisting of four subtests. The score from each index is scaled by the age group with the scaled score mean to be 100 and standard deviation equals to 15, then the total RBANS scored is summed up of these indexes with the same normal mean and standard deviation. The lower the RBANS score the patient receives, the grave cognitive declination appears.
Measured: 4 weeks
major depressive disorders assessed on Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
The classification of major depressive disorder has been updated in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorder (DSM-V). It is defined by the lifetime absence of mania and hypomania, as well as one or more major depressive episodes. DSM description includes the diagnostic classification, the diagnostic criteria sets and the descriptive text. The diagnostic classification represents the official list of mental disorder with diagnostic codes that used by all U.S. health care professionals. The diagnostic criteria, specifically, the criteria for major depressive disorder consists: five or more out of nine related symptoms, symptoms cause significant distress or impairment, episode has not attribute to any substance or medical condition, the absent of psychotic disorder, the absent of any manic or hypomanic episode. Last but not the least, the descriptive text provides information like diagnostic features, diagnostic measures and functional consequences.
Measured: 4 weeks

Secondary outcomes (1)

Side effect assessed on UKU
The Udvalg for Kliniske Under-sogelser (UKU) side effect rating scale is a clinician-rated assessment uses to capture the side effects of psychotropic drug doses.
It consists three parts: The first part, the single symptom rating scale. The scoring level may varied on the individual items but the general scale remains the same principle: 0= not or doubtfully present, 1 = present to a mild degree, 2 = present to a moderate degree, 3 = present to a severe degree. The greater level indicate, the severe the symptom becomes. The second part is a global assessment, where as 0 refers to no effect and 3 represents side effects that interfere moderately with the patient's performance. The last component is a statement of the results that the patient's side effects have for following up the medication. The decision are listed as from 0, "no action", to 3, "discontinuation of drug or changes to another preparation". The larger the number appears, the greater demand of intervention.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201830 Jan 2020

First posted13 Aug 2019
Study start1 Dec 2018
Primary completion30 Dec 2019
Study completion30 Jan 2020

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 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 800 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04055181
Sponsor's protocol ID: CASPsy2
Status last verified: Jun 2021
First submitted: 14 Jul 2019
Last updated: 9 Jun 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data with be available on request

Publications

Kozak K, Sharif-Razi M, Morozova M, Gaudette EV, Barr MS, Daskalakis ZJ, Blumberger DM, George TP. Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls. Schizophr Res. 2018 Jul;197:441-443. doi: 10.1016/j.schres.2018.02.015. Epub 2018 Feb 24.
PubMed 29486960
Prikryl R, Ustohal L, Kucerova HP, Kasparek T, Jarkovsky J, Hublova V, Vrzalova M, Ceskova E. Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. Prog Neuropsychopharmacol Biol Psychiatry. 2014 Mar 3;49:30-5. doi: 10.1016/j.pnpbp.2013.10.019. Epub 2013 Nov 6.
PubMed 24211840
Huang W, Shen F, Zhang J, Xing B. Effect of Repetitive Transcranial Magnetic Stimulation on Cigarette Smoking in Patients with Schizophrenia. Shanghai Arch Psychiatry. 2016 Dec 25;28(6):309-317. doi: 10.11919/j.issn.1002-0829.216044.
PubMed 28638206
Zvolensky MJ, Bakhshaie J, Sheffer C, Perez A, Goodwin RD. Major depressive disorder and smoking relapse among adults in the United States: a 10-year, prospective investigation. Psychiatry Res. 2015 Mar 30;226(1):73-7. doi: 10.1016/j.psychres.2014.11.064. Epub 2014 Dec 9.
PubMed 25650047
Benadhira R, Thomas F, Bouaziz N, Braha S, Andrianisaina PS, Isaac C, Moulier V, Januel D. A randomized, sham-controlled study of maintenance rTMS for treatment-resistant depression (TRD). Psychiatry Res. 2017 Dec;258:226-233. doi: 10.1016/j.psychres.2017.08.029. Epub 2017 Aug 18.
PubMed 28844559

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of rTMS on Symptoms and Cognition in Patients With Psychiatric Disorders
ClinicalTrials.gov ID: NCT04055181
Acronym / sponsor ID: CASPsy2
Conditions: Schizophrenia, Major Depressive Disorder
Keywords: schizophrenia, smoking, rTMS, major depressive disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 800 participants (actual)
Lead sponsor: Beijing HuiLongGuan HospitalUniversity, hospital or other
Study start: 1 Dec 2018 (actual)
Primary completion: 30 Dec 2019 (actual)
Study completion: 30 Jan 2020 (actual)
First posted: 13 Aug 2019 (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.

Detailed description

METHODS:

Clinical Trial：The study consists of 4 weeks of treatment.
Assess Procedures:

2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at baseline, 4 weeks, and 16 weeks.

2.3 Weight gain measurement: weight gain every week

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
rTMS in schizophrenia patients	Active comparator	Device: rTMS in schizophrenia patientsIn active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks
rTMS in schizophrenia Controls	Sham comparator	Device: rTMS in schizophrenia ControlsIn sham rTMS, all procedures were identical to 10Hz Schizophrenia group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
rTMS in major depressive disorders patients	Active comparator	Device: rTMS in major depressive disorders patientsIn active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks
rTMS in major depressive disorders controls	Sham comparator	Device: rTMS in major depressive disorders controlsIn sham rTMS, all procedures were identical to 10Hz depression group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Diagnosis of schizophrenia by two senior psychiatrists
Between 18 and 60 years and Han Chinese
Duration of symptoms at least 12 months
With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS < 24)
Smoking

Key exclusion criteria (7 listed)

Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
Severe headache for unknown reasons and cardiovascular diseases, intracranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months
Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures
Education level less than 5 years by subject report

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
rTMS in schizophrenia Controlsall procedures were identical to "rTMS in schizophrenia patients" group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.	Device	rTMS in schizophrenia Controls
rTMS in schizophrenia patients10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks	Device	rTMS in schizophrenia patients
rTMS in major depressive disorders controlsall procedures were identical to "rTMS in major depressive disorders patients" group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.	Device	rTMS in major depressive disorders controls
rTMS in major depressive disorders patients10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks	Device	rTMS in major depressive disorders patients

Primary outcome

symptoms assessed on PANSS
Time frame: 4 weeks
The Positive and Negative Syndrome Scale is often shorted as PANSS. It is a well-characterized and well-applied measurement instrument that measures positive and negative syndromes, their differential and general severity of illness. The items on the PANSS are defined with increasing levels from 1 to 7, the greater the value appears, the severe the level is: 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate-severe, 6 = severe, and 7 = extreme. The PANSS score is finalized by summation of ratings across different items, the potential range for positive and negative scales are from 7 to 49 whereas the General Psychopathology Scale is ranged between 16 to 112.
cognitive functioning assessed on RBANS
Time frame: 4 weeks
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a test for identifying and characterizing abnormal cognitive decline in the elders and examining neuropsychological disorders for younger adults. The RBANS is comprised of five domains, which are Immediate Memory, Visuospatial /Constructional, Language, Attention and Delayed Memory. Each of the five index is based on two subtests except Delayed memory index consisting of four subtests. The score from each index is scaled by the age group with the scaled score mean to be 100 and standard deviation equals to 15, then the total RBANS scored is summed up of these indexes with the same normal mean and standard deviation. The lower the RBANS score the patient receives, the grave cognitive declination appears.
major depressive disorders assessed on Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
Time frame: 4 weeks
The classification of major depressive disorder has been updated in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorder (DSM-V). It is defined by the lifetime absence of mania and hypomania, as well as one or more major depressive episodes. DSM description includes the diagnostic classification, the diagnostic criteria sets and the descriptive text. The diagnostic classification represents the official list of mental disorder with diagnostic codes that used by all U.S. health care professionals. The diagnostic criteria, specifically, the criteria for major depressive disorder consists: five or more out of nine related symptoms, symptoms cause significant distress or impairment, episode has not attribute to any substance or medical condition, the absent of psychotic disorder, the absent of any manic or hypomanic episode. Last but not the least, the descriptive text provides information like diagnostic features, diagnostic measures and functional consequences.

1 secondary outcome

Side effect assessed on UKU
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Background: PubMed 29486960Kozak K, Sharif-Razi M, Morozova M, Gaudette EV, Barr MS, Daskalakis ZJ, Blumberger DM, George TP. Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls. Schizophr Res. 2018 Jul;197:441-443. doi: 10.1016/j.schres.2018.02.015. Epub 2018 Feb 24.
Background: PubMed 24211840Prikryl R, Ustohal L, Kucerova HP, Kasparek T, Jarkovsky J, Hublova V, Vrzalova M, Ceskova E. Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. Prog Neuropsychopharmacol Biol Psychiatry. 2014 Mar 3;49:30-5. doi: 10.1016/j.pnpbp.2013.10.019. Epub 2013 Nov 6.
Background: PubMed 28638206Huang W, Shen F, Zhang J, Xing B. Effect of Repetitive Transcranial Magnetic Stimulation on Cigarette Smoking in Patients with Schizophrenia. Shanghai Arch Psychiatry. 2016 Dec 25;28(6):309-317. doi: 10.11919/j.issn.1002-0829.216044.
Background: PubMed 25650047Zvolensky MJ, Bakhshaie J, Sheffer C, Perez A, Goodwin RD. Major depressive disorder and smoking relapse among adults in the United States: a 10-year, prospective investigation. Psychiatry Res. 2015 Mar 30;226(1):73-7. doi: 10.1016/j.psychres.2014.11.064. Epub 2014 Dec 9.
Background: PubMed 28844559Benadhira R, Thomas F, Bouaziz N, Braha S, Andrianisaina PS, Isaac C, Moulier V, Januel D. A randomized, sham-controlled study of maintenance rTMS for treatment-resistant depression (TRD). Psychiatry Res. 2017 Dec;258:226-233. doi: 10.1016/j.psychres.2017.08.029. Epub 2017 Aug 18.
Individual participant dataSharing planned: No. Data with be available on request

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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.

Xiang Y Zhang, MD,PhD principal investigator

Institute of Psychology, Chinese Academy of Sciences

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

symptoms assessed on PANSS (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 NCT04055181, 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 9 Jun 2021.