DepressionPhase 4NCT03863925
Comparison of Propofol Target-Controlled Infusion Anesthesia and Bolus Injection in Electroconvulsive Therapy
A Phase 4 study testing Bolus injection of Propofol in people with Depression and Schizophrenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Electroconvulsive therapy (ECT) serves as an effective adjuvant or alternative modality for major depressive disorder, schizophrenia, or bipolar affective disorder refractory to or contraindicated to psychopharmacological treatment. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Depression, Schizophrenia, Bipolar Disorder
- What is being tested?
- Bolus injection of Propofol
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2017to 2 Feb 2019
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 years old and 65 years old
- Diagnosis of major depressive disorder, bipolar disorder, and schizophrenia, compatible with SCID for DSM-5, with clinical necessity of ECT under a psychiatrist's evaluation and decision
- Patients with adequate visual acuity and auditory acuity without or with correction
- Patients or patients' legal representative signing up the informed consent
Who cannot join
- Patients already diagnosed with neurocognitive disorder
- Patients with contraindications to ECT, including myocardial infarction, cerebrovascular disease, elevated intracranial pressure, intracranial angiomas, untreated bony fractures, cervical spine injury, pheochromocytoma, heart failure, sever valvular disease, deep vein thrombosis, etc.
- Patients with untreated substance abuse, including alcohol and illegal drugs
- Patients with unspecified psychiatric disorders
- Patients unable to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Propofol Target-Controlled Infusion Anesthesia and Bolus Injection in Electroconvulsive Therapy: A Randomized Controlled Trial
Electroconvulsive therapy (ECT) serves as an effective adjuvant or alternative modality for major depressive disorder, schizophrenia, or bipolar affective disorder refractory to or contraindicated to psychopharmacological treatment. Anesthetics have been introduced into ECT sessions to alleviate ECT-inducing discomfort sensation, tachycardia, arrhythmia, hypertension, and anxiety. Propofol is highly lipid soluble and able to rapidly cross the blood-brain barrier (BBB), which leads to rapid onset of sedation and hypnosis. Meanwhile, propofol has hemodynamic depressant effect and attenuates hypertensive surge during ECT. Characteristics mentioned above make propofol one of widely used anesthetics for anesthetized ECT.
Propofol can be administered with bolus injection or target-controlled infusion (TCI). Compared with bolus injection, TCI provides relatively constant concentration at site of interest based on computer simulation with input of pharmacokinetic parameters, such as age, body weight, body height, etc. However, propofol is also well known for anticonvulsant property, which may inevitably interfere with seizure propagation by electroconvulsive stimulus and diminish consequent efficacy. Thus, dosage of electrical stimulus may be increased to achieve ideal seizure quality in this setting, which also leads to higher risk of subsequent cognitive impairment.
In our clinical practice, TCI system reduces total amount of propofol in comparison with bolus injection method. Therefore, we hypothesize that application of TCI system in anesthetized ECT relates to lower dosage of electrical stimulus and decreased incidence or severity of post-treatment cognitive impairment.
Read the detailed description
Electroconvulsive therapy (ECT) serves as an effective adjuvant or alternative modality for major depressive disorder, schizophrenia, or bipolar affective disorder refractory to or contraindicated to psychopharmacological treatment. Anesthetics have been introduced into ECT sessions to alleviate ECT-inducing discomfort sensation, tachycardia, arrhythmia, hypertension, and anxiety. Propofol is highly lipid soluble and able to rapidly cross the blood-brain barrier (BBB), which leads to rapid onset of sedation and hypnosis. Meanwhile, propofol has hemodynamic depressant effect and attenuates hypertensive surge during ECT. Characteristics mentioned above make propofol one of widely used anesthetics for anesthetized ECT.
Propofol can be administered with bolus injection or target-controlled infusion (TCI). Compared with bolus injection, TCI provides relatively constant concentration at site of interest based on computer simulation with input of pharmacokinetic parameters, such as age, body weight, body height, etc. However, propofol is also well known for anticonvulsant property, which may inevitably interfere with seizure propagation by electroconvulsive stimulus and diminish consequent efficacy. Thus, dosage of electrical stimulus may be increased to achieve ideal seizure quality in this setting, which also leads to higher risk of subsequent cognitive impairment.
In our clinical practice, TCI system reduces total amount of propofol in comparison with bolus injection method. Therefore, we hypothesize that application of TCI system in anesthetized ECT relates to lower dosage of electrical stimulus and decreased incidence or severity of post-treatment cognitive impairment.
- Conditions
- Depression, Schizophrenia, Bipolar Disorder, Cognitive Dysfunction
- Being tested
- Target controlled infusion, Schnider model, Bolus injection of Propofol
- Keywords
- Electroconvulsive therapy, Propofol, Target controlled infusion
- Medical subject headings
- Depression, Schizophrenia, Bipolar Disorder, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target controlled infusion, Schnider modelDevice
Target controlled infusion (TCI) is an intravenous drug delivery system estimating pharmacokinetics after input of patient's data, e.g. age, sex, body height, body weight. Schnider model is one of TCI model to deliver Propofol. After target concentration at effect site (e.g. the brain) is keyed in, the computerized infusion pump will calculate dosage of bolus and infusion rate for each individual, and calculated concentration of propofol at plasma and brain will be displayed. The clinicians should evaluate the patient's sedation level in response to calculated propofol concentration and titrate target concentration to achieve desired sedation level.
Bolus injection of PropofolBehavioural
Bolus intravenous injection is a traditional way to deliver anesthetic, and the dosage and amount of medication is based on clinical experience and patients' response.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Target Controlled Infusion Group (Group T) | Experimental | Patients in group T underwent anesthesia with Propofol (dosage form: 10mg/mL) target controlled infusion by Schnider model, starting at concentration of effect site (Ce) of 1.5 mcg/mL and titrating to achieve Observer's Assessment of Alertness/Sedation (OAA/S) Scale level 3 (responds only after name called loudly or repeatedly). Patients were paralyzed with suxamethonium (dosage form: 20mg/mL; dosage: 1mg/kg) once adequate sedation level achieved. TCI was stopped once the psychiatrist applied electroconvulsive stimulation to patients' bilateral frontal regions. Assisted ventilation with bag-valve-mask device by experienced anesthesiologists was began since patients were sedated until adequate spontaneous respiration was regained after each single electroconvulsive therapy (ECT) session. Every patient receive total six to twelve ECT sessions, and each ECT session was conducted one day apart. Receives: Device: Target controlled infusion, Schnider model |
| Propofol Bolus Group (Group B) | Active comparator | Patients in group B underwent anesthesia with bolus of propofol for sedation, and the dosage raged between 0.75 to 1.5 mg/kg to achieve at least OAA/S scale level 3. Dosage of suxamethonium, application of electroconvulsive stimulation, ventilation maneuver, frequency of ECT session, and number of total ECT sessions were same as patients in group T. Receives: Behavioral: Bolus injection of Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Clinical Global Impression-Severity (CGI-S)
Evaluation with Clinical Global Impression-Severity (CGI-S)
Measured: through study completion, an average of one month
Change from baseline Clinical Global Impression-Improvement (CGI-I)
Evaluation with Clinical Global Impression-Improvement (CGI-I)
Measured: through study completion, an average of one month
Secondary outcomes (1)
Cognitive dysfunction
Evaluation with Montreal Cognitive Assessment (MoCA)
Measured: through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start15 Aug 2017
- Primary completion1 Feb 2019
- Study completion2 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Ling Hsieh, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863925
- Sponsor's protocol ID
- 201700862A3
- Status last verified
- Aug 2017
- First submitted
- 25 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Semkovska M, McLoughlin DM. Objective cognitive performance associated with electroconvulsive therapy for depression: a systematic review and meta-analysis. Biol Psychiatry. 2010 Sep 15;68(6):568-77. doi: 10.1016/j.biopsych.2010.06.009. Epub 2010 Jul 31.
PubMed 20673880Sackeim HA, Prudic J, Fuller R, Keilp J, Lavori PW, Olfson M. The cognitive effects of electroconvulsive therapy in community settings. Neuropsychopharmacology. 2007 Jan;32(1):244-54. doi: 10.1038/sj.npp.1301180. Epub 2006 Aug 23.
PubMed 16936712McClintock SM, Choi J, Deng ZD, Appelbaum LG, Krystal AD, Lisanby SH. Multifactorial determinants of the neurocognitive effects of electroconvulsive therapy. J ECT. 2014 Jun;30(2):165-76. doi: 10.1097/YCT.0000000000000137.
PubMed 24820942Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Sakamoto A, Hoshino T, Suzuki N, Suzuki H, Kimura M, Ogawa R. Effects of propofol anesthesia on cognitive recovery of patients undergoing electroconvulsive therapy. Psychiatry Clin Neurosci. 1999 Dec;53(6):655-60. doi: 10.1046/j.1440-1819.1999.00621.x.
PubMed 10687746Imashuku Y, Kanemoto K, Senda M, Matsubara M. Relationship between blood levels of propofol and recovery of memory in electroconvulsive therapy. Psychiatry Clin Neurosci. 2014 Apr;68(4):270-4. doi: 10.1111/pcn.12122. Epub 2013 Dec 8.
PubMed 24313665Galvez V, Hadzi-Pavlovic D, Wark H, Harper S, Leyden J, Loo CK. The Anaesthetic-ECT Time Interval in Electroconvulsive Therapy Practice--Is It Time to Time? Brain Stimul. 2016 Jan-Feb;9(1):72-7. doi: 10.1016/j.brs.2015.09.005. Epub 2015 Sep 12.
PubMed 26452698Struys MM, De Smet T, Glen JI, Vereecke HE, Absalom AR, Schnider TW. The History of Target-Controlled Infusion. Anesth Analg. 2016 Jan;122(1):56-69. doi: 10.1213/ANE.0000000000001008.
PubMed 26516804Hsieh ML, Lu YT, Lin CC, Lee CP. Comparison of the target-controlled infusion and the manual infusion of propofol anesthesia during electroconvulsive therapy: an open-label randomized controlled trial. BMC Psychiatry. 2021 Feb 4;21(1):71. doi: 10.1186/s12888-021-03069-6.
PubMed 33541306
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol Target-Controlled Infusion Anesthesia and Bolus Injection in Electroconvulsive Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03863925
- Acronym / sponsor ID
- 201700862A3
- Conditions
- Depression, Schizophrenia, Bipolar Disorder, Cognitive Dysfunction
- Keywords
- Electroconvulsive therapy, Propofol, Target controlled infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 2 Feb 2019 (actual)
- First posted
- 5 Mar 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.
Electroconvulsive therapy (ECT) serves as an effective adjuvant or alternative modality for major depressive disorder, schizophrenia, or bipolar affective disorder refractory to or contraindicated to psychopharmacological treatment. Anesthetics have been introduced into ECT sessions to alleviate ECT-inducing discomfort sensation, tachycardia, arrhythmia, hypertension, and anxiety. Propofol is highly lipid soluble and able to rapidly cross the blood-brain barrier (BBB), which leads to rapid onset of sedation and hypnosis. Meanwhile, propofol has hemodynamic depressant effect and attenuates hypertensive surge during ECT. Characteristics mentioned above make propofol one of widely used anesthetics for anesthetized ECT.
Propofol can be administered with bolus injection or target-controlled infusion (TCI). Compared with bolus injection, TCI provides relatively constant concentration at site of interest based on computer simulation with input of pharmacokinetic parameters, such as age, body weight, body height, etc. However, propofol is also well known for anticonvulsant property, which may inevitably interfere with seizure propagation by electroconvulsive stimulus and diminish consequent efficacy. Thus, dosage of electrical stimulus may be increased to achieve ideal seizure quality in this setting, which also leads to higher risk of subsequent cognitive impairment.
In our clinical practice, TCI system reduces total amount of propofol in comparison with bolus injection method. Therefore, we hypothesize that application of TCI system in anesthetized ECT relates to lower dosage of electrical stimulus and decreased incidence or severity of post-treatment cognitive impairment.
Detailed description
Electroconvulsive therapy (ECT) serves as an effective adjuvant or alternative modality for major depressive disorder, schizophrenia, or bipolar affective disorder refractory to or contraindicated to psychopharmacological treatment. Anesthetics have been introduced into ECT sessions to alleviate ECT-inducing discomfort sensation, tachycardia, arrhythmia, hypertension, and anxiety. Propofol is highly lipid soluble and able to rapidly cross the blood-brain barrier (BBB), which leads to rapid onset of sedation and hypnosis. Meanwhile, propofol has hemodynamic depressant effect and attenuates hypertensive surge during ECT. Characteristics mentioned above make propofol one of widely used anesthetics for anesthetized ECT.
Propofol can be administered with bolus injection or target-controlled infusion (TCI). Compared with bolus injection, TCI provides relatively constant concentration at site of interest based on computer simulation with input of pharmacokinetic parameters, such as age, body weight, body height, etc. However, propofol is also well known for anticonvulsant property, which may inevitably interfere with seizure propagation by electroconvulsive stimulus and diminish consequent efficacy. Thus, dosage of electrical stimulus may be increased to achieve ideal seizure quality in this setting, which also leads to higher risk of subsequent cognitive impairment.
In our clinical practice, TCI system reduces total amount of propofol in comparison with bolus injection method. Therefore, we hypothesize that application of TCI system in anesthetized ECT relates to lower dosage of electrical stimulus and decreased incidence or severity of post-treatment cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Target Controlled Infusion Group (Group T) | Experimental | Device: Target controlled infusion, Schnider modelPatients in group T underwent anesthesia with Propofol (dosage form: 10mg/mL) target controlled infusion by Schnider model, starting at concentration of effect site (Ce) of 1.5 mcg/mL and titrating to achieve Observer's Assessment of Alertness/Sedation (OAA/S) Scale level 3 (responds only after name called loudly or repeatedly). Patients were paralyzed with suxamethonium (dosage form: 20mg/mL; dosage: 1mg/kg) once adequate sedation level achieved. TCI was stopped once the psychiatrist applied electroconvulsive stimulation to patients' bilateral frontal regions. Assisted ventilation with bag-valve-mask device by experienced anesthesiologists was began since patients were sedated until adequate spontaneous respiration was regained after each single electroconvulsive therapy (ECT) session. Every patient receive total six to twelve ECT sessions, and each ECT session was conducted one day apart. |
| Propofol Bolus Group (Group B) | Active comparator | Behavioral: Bolus injection of PropofolPatients in group B underwent anesthesia with bolus of propofol for sedation, and the dosage raged between 0.75 to 1.5 mg/kg to achieve at least OAA/S scale level 3. Dosage of suxamethonium, application of electroconvulsive stimulation, ventilation maneuver, frequency of ECT session, and number of total ECT sessions were same as patients in group T. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 20 years old and 65 years old
- Diagnosis of major depressive disorder, bipolar disorder, and schizophrenia, compatible with SCID for DSM-5, with clinical necessity of ECT under a psychiatrist's evaluation and decision
- Patients with adequate visual acuity and auditory acuity without or with correction
- Patients or patients' legal representative signing up the informed consent
Key exclusion criteria (5 listed)
- Patients already diagnosed with neurocognitive disorder
- Patients with contraindications to ECT, including myocardial infarction, cerebrovascular disease, elevated intracranial pressure, intracranial angiomas, untreated bony fractures, cervical spine injury, pheochromocytoma, heart failure, sever valvular disease, deep vein thrombosis, etc.
- Patients with untreated substance abuse, including alcohol and illegal drugs
- Patients with unspecified psychiatric disorders
- Patients unable to cooperate
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 |
|---|---|---|
| Target controlled infusion, Schnider modelTarget controlled infusion (TCI) is an intravenous drug delivery system estimating pharmacokinetics after input of patient's data, e.g. age, sex, body height, body weight. Schnider model is one of TCI model to deliver Propofol. After target concentration at effect site (e.g. the brain) is keyed in, the computerized infusion pump will calculate dosage of bolus and infusion rate for each individual, and calculated concentration of propofol at plasma and brain will be displayed. The clinicians should evaluate the patient's sedation level in response to calculated propofol concentration and titrate target concentration to achieve desired sedation level. | Device | Propofol Target Controlled Infusion Group (Group T) |
| Bolus injection of PropofolBolus intravenous injection is a traditional way to deliver anesthetic, and the dosage and amount of medication is based on clinical experience and patients' response. | Behavioural | Propofol Bolus Group (Group B) |
Primary outcome
Change from baseline Clinical Global Impression-Severity (CGI-S)
Time frame: through study completion, an average of one month
Evaluation with Clinical Global Impression-Severity (CGI-S)
Change from baseline Clinical Global Impression-Improvement (CGI-I)
Time frame: through study completion, an average of one month
Evaluation with Clinical Global Impression-Improvement (CGI-I)
1 secondary outcome
Cognitive dysfunction
Time frame: through study completion, an average of one month
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 5 Mar 2019.
- Background: PubMed 20673880Semkovska M, McLoughlin DM. Objective cognitive performance associated with electroconvulsive therapy for depression: a systematic review and meta-analysis. Biol Psychiatry. 2010 Sep 15;68(6):568-77. doi: 10.1016/j.biopsych.2010.06.009. Epub 2010 Jul 31.
- Background: PubMed 16936712Sackeim HA, Prudic J, Fuller R, Keilp J, Lavori PW, Olfson M. The cognitive effects of electroconvulsive therapy in community settings. Neuropsychopharmacology. 2007 Jan;32(1):244-54. doi: 10.1038/sj.npp.1301180. Epub 2006 Aug 23.
- Background: PubMed 24820942McClintock SM, Choi J, Deng ZD, Appelbaum LG, Krystal AD, Lisanby SH. Multifactorial determinants of the neurocognitive effects of electroconvulsive therapy. J ECT. 2014 Jun;30(2):165-76. doi: 10.1097/YCT.0000000000000137.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 10687746Sakamoto A, Hoshino T, Suzuki N, Suzuki H, Kimura M, Ogawa R. Effects of propofol anesthesia on cognitive recovery of patients undergoing electroconvulsive therapy. Psychiatry Clin Neurosci. 1999 Dec;53(6):655-60. doi: 10.1046/j.1440-1819.1999.00621.x.
- Background: PubMed 24313665Imashuku Y, Kanemoto K, Senda M, Matsubara M. Relationship between blood levels of propofol and recovery of memory in electroconvulsive therapy. Psychiatry Clin Neurosci. 2014 Apr;68(4):270-4. doi: 10.1111/pcn.12122. Epub 2013 Dec 8.
- Background: PubMed 26452698Galvez V, Hadzi-Pavlovic D, Wark H, Harper S, Leyden J, Loo CK. The Anaesthetic-ECT Time Interval in Electroconvulsive Therapy Practice--Is It Time to Time? Brain Stimul. 2016 Jan-Feb;9(1):72-7. doi: 10.1016/j.brs.2015.09.005. Epub 2015 Sep 12.
- Background: PubMed 26516804Struys MM, De Smet T, Glen JI, Vereecke HE, Absalom AR, Schnider TW. The History of Target-Controlled Infusion. Anesth Analg. 2016 Jan;122(1):56-69. doi: 10.1213/ANE.0000000000001008.
- Derived from this study: PubMed 33541306Hsieh ML, Lu YT, Lin CC, Lee CP. Comparison of the target-controlled infusion and the manual infusion of propofol anesthesia during electroconvulsive therapy: an open-label randomized controlled trial. BMC Psychiatry. 2021 Feb 4;21(1):71. doi: 10.1186/s12888-021-03069-6.
- Individual participant dataSharing planned: Undecided
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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.
Meng Ling Hsieh principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bolus injection of Propofol in people with Depression and Schizophrenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 5 Mar 2019. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline Clinical Global Impression-Severity (CGI-S) (time frame: through study completion, an average of one month). The study lists 2 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 NCT03863925, which also lists 9 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 5 Mar 2019.