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SchizophreniaPhase 3NCT03510325

Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT)

A Phase 3 study testing Phase 1: Olanzapine, Phase 1: Risperidone and Phase 1: Amisulpride in people with Schizophrenia, run by Shanghai Mental Health Center at 7 sites in China.

Completed

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

Official record
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Trial summary

This study is a sequential multiple-assignment randomized trial (RCT) of antipsychotic medication treatment in first-episode schizophrenia patients in the real-world settings.Through analysis of treatment efficacy rate and adverse reactions and pharmacoeconomic evaluation, this project intends to provide evidence for… Read more about this study

Who is it for?
Ages 16 to 45 years
Conditions the study is for
Schizophrenia
What is being tested?
Phase 1: Olanzapine, Phase 1: Risperidone and Phase 1: Amisulpride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
762 participants
Where
7 sitesChina
Study dates
12 Feb 2019to 27 Sep 2023
Phase
Phase 3
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 16 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients must meet the DSM-5 diagnostic criteria for schizophrenia , schizophreniform disorder or schizoaffective disorder, based upon the structured clinical interview by research psychiatrist using Mini International Neuropsychiatric Interview 7.0 (M.I.N.I. 7.0), review of their clinical records, and input from available informants.
  • Inpatients or outpatients.
  • 16-45 years of age.
  • First episode, and the course no more than 3 years.
  • Drug-naïve, or any antipsychotic medication had been used no more than 2 weeks, and the cumulative antipsychotic drug exposure time no more than 6 weeks in lifetime.
  • The severity of psychotic symptoms is moderate or above, and the specific criteria including: have a score ≥4 on at least one item of Positive and Negative Syndrome Scale (PANSS) (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, or suspiciousness/persecution), and PANSS total score >70.
  • Patients must demonstrate adequate decisional capacity to make a choice about participating in this research study and must provide informed consent to participate.

Who cannot join

  • Patients were excluded if more than 3 years had passed since the onset of psychosis;
  • They met any of the contraindications for any of the study drugs;
  • Mental symptoms were caused by organic disease, severe physical illness, psychoactive substance dependence, mental retardation;
  • They were pregnancy or breast-feeding; they were extreme agitation, stupor or negative suicide.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Anding Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100000

  • Dalian Seventh People's Hospital

    Dalian, Liaoning, 116000

  • Hangzhou Seventh People's Hospital

    Hangzhou, Zhejiang, 310000

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

  • Nanjing Brain Hospital Affiliated to Nanjing Medical University

    Nanjing, Jiangsu, 210000

  • Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200030

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430000

Other trials in China

About this study

Official title: Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments

This study is a sequential multiple-assignment randomized trial (RCT) of antipsychotic medication treatment in first-episode schizophrenia patients in the real-world settings.Through analysis of treatment efficacy rate and adverse reactions and pharmacoeconomic evaluation, this project intends to provide evidence for the selection of antipsychotics in FES patients as well as the efficacy and safety of using clozapine in the early phase of schizophrenia treatment by comparing with other SGAs.

Read the detailed description

A total of 720 first-episode schizophrenia (FES) patients will be enrolled and followed up for 12 months in this study. The trial includes three treatment phases (each phase lasting for 8 weeks) and a naturalistic follow-up phase. Phase 1 is a 8-week randomized controlled trial; patients will be randomly assigned to one of the treatments with oral olanzapine, risperidone, amisulpride, aripiprazole or perphenazine. Patients who had an acceptable response to the randomly assigned drug therapy will remain on that treatment for a 12-month treatment period. Subjects who fail to respond in phase 1 will switch to phase 2, an equipoise-stratified randomization trial, in which patients will be randomly assigned to oral olanzapine, amisulpride or clozapine for another 8 weeks. No-responders in phase 2 will further enter an open label trial (phase 3). Patients who receive clozapine in phase 2 will be assigned to an extended clozapine treatment or modified electroconvulsive therapy add-on therapy (Phase 3A). Patients who were not assigned to clozapine in phase 2 will be assigned to treatment with clozapine or another SGAs not previously used in phase 1 and 2 (Phase 3B).

Conditions
Schizophrenia
Being tested
Phase 1: Olanzapine, Phase 1: Risperidone, Phase 1: Amisulpride, Phase 1: Aripiprazole, Phase 1: Perphenazine
Keywords
Schizophrenia;, Antipsychotics；, first-episode;, switch
Medical subject headings
Schizophrenia

What participants receive

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

  • Phase 1: OlanzapineDrug

    Initial dosage: 5-10 mg; recommended dosage: 5-20 mg/d; dosage form: po. duration: 8 weeks

  • Phase 1: RisperidoneDrug

    Initial dosage: 1-2 mg; recommended dosage: 2-6 mg/d; dosage form: po. duration: 8 weeks

  • Phase 1: AmisulprideDrug

    Initial dosage: 200-400 mg; recommended dosage: 400-1200 mg/d; dosage form: po. duration: 8 weeks

  • Phase 1: AripiprazoleDrug

    Initial dosage: 5-10 mg; recommended dosage: 10-30 mg/d; dosage form: po. duration: 8 weeks

  • Phase 1: PerphenazineDrug

    Initial dosage: 2-4 mg; recommended dosage: 6-36 mg/d; dosage form: po. duration: 8 weeks

  • Phase 2: OlanzapineDrug

    Initial dosage: 5-10 mg; recommended dosage: 5-20 mg/d; dosage form: po. duration: 8 weeks

  • Phase 2: AmisulprideDrug

    Initial dosage: 200-400 mg; recommended dosage: 400-1200 mg/d; dosage form: po. duration: 8 weeks

  • Phase 2: ClozapineDrug

    Initial dosage: 25-50 mg; recommended dosage: 200-400 mg/d; dosage form: po. duration: 8 weeks

  • Phase 3A: Clozapine extended treatment or Combined clozapine-MECT therapyOther

    Clozapine extended treatment:

    dosage: 200-600 mg/d; dosage form: po.

    Combined clozapine-MECT therapy:

    Dosage of clozapine: 200-600 mg/d; The modified electroconvulsive therapy (MECT) will be administered three times per week for the first 2 weeks, then twice a week for the next 2 weeks. The total treatment duration is about one month.

  • Phase 3B: Clozapine or another SGAsDrug

    Clozapine:

    Initial dosage: 25-50 mg; recommended dosage: 200-600 mg/d; duration: 8 weeks

    Another Second generation antipsychotics (SGAs) (not previously used in phase 1 and 2): Olanzapine, risperidone, amisulpride, or aripiprazole The dosage of each drug is the same as that of phase 1 and phase 2.

Study groups in NCT03510325
Study groupRoleWhat they receive
【Phase 1】 Olanzapine RCTExperimentalPhase 1 of the trial is a 8-week randomized controlled trial (RCT); patients will be randomly assigned to one of five treatment arms with different oral antipsychotics, one of which is 'Olanzapine RCT'. Non-responders or patients with intolerable side effects in phase 1 will switch to phase 2.
Receives: Drug: Phase 1: Olanzapine
【Phase 1】 Risperidone RCTExperimentalPhase 1 of the trial is a 8-week randomized controlled trial (RCT); patients will be randomly assigned to one of five treatment arms with different oral antipsychotics, one of which is 'Risperidone RCT'. Non-responders or patients with intolerable side effects in phase 1 will switch to phase 2.
Receives: Drug: Phase 1: Risperidone
【Phase 1】 Amisulpride RCTExperimentalPhase 1 of the trial is a 8-week randomized controlled trial (RCT); patients will be randomly assigned to one of five treatment arms with different oral antipsychotics, one of which is 'Amisulpride RCT'. Non-responders or patients with intolerable side effects in phase 1 will switch to phase 2.
Receives: Drug: Phase 1: Amisulpride
【Phase 1】 Aripiprazole RCTExperimentalPhase 1 of the trial is a 8-week randomized controlled trial (RCT); patients will be randomly assigned to one of five 8-week treatment arms with different oral antipsychotics, one of which is 'Aripiprazole RCT'. Non-responders or patients with intolerable side effects in phase 1 will switch to phase 2.
Receives: Drug: Phase 1: Aripiprazole
【Phase 1】 Perphenazine RCTExperimentalPhase 1 of the trial is a 8-week randomized controlled trial (RCT); patients will be randomly assigned to one of five treatment arms with different oral antipsychotics, one of which is 'Perphenazine RCT'. Non-responders or patients with intolerable side effects in phase 1 will switch to phase 2.
Receives: Drug: Phase 1: Perphenazine
【Phase 2】 Olanzapine ESRExperimentalNon-responders or patients with intolerable side effects in phase 1 will switch to phase 2, a 8-week equipoise-stratified randomization (ESR) trial; patients treated with risperidone, amisulpride, aripiprazole or perphenazine in phase 1 will be randomly assigned to one of three treatment arms, one of which is 'Olanzapine ESR'. Non-responders or patients with intolerable side effects in phase 2 will switch to phase 3.
Receives: Drug: Phase 2: Olanzapine
【Phase 2】 Amisulpride ESRExperimentalNon-responders or patients with intolerable side effects in phase 1 will switch to phase 2, a 8-week equipoise-stratified randomization (ESR) trial; patients treated with olanzapine, risperidone, aripiprazole or perphenazine in phase 1 will be randomly assigned to one of three treatment arms, one of which is 'Amisulpride ESR'. Non-responders or patients with intolerable side effects in phase 2 will switch to phase 3.
Receives: Drug: Phase 2: Amisulpride
【Phase 2】 Clozapine ESRExperimentalNon-responders or patients with intolerable side effects in phase 1 will switch to phase 2, a 8-week equipoise-stratified randomization (ESR) trial; patients in phase 1 will be randomly assigned to one of three treatment arms, one of which is 'Clozapine ESR'. Non-responders or patients with intolerable side effects in phase 2 will switch to phase 3.
Receives: Drug: Phase 2: Clozapine
【Phase 3】 Clozapine extended treatment or MECT add-on therapyExperimentalIf a patient received clozapine in phase 2 failed to response, the individual will be assigned to the clozapine extended treatment or modified electroconvulsive therapy (MECT) add-on therapy.
Receives: Other: Phase 3A: Clozapine extended treatment or Combined clozapine-MECT therapy
【Phase 3】 Clozapine or another SGAs (olanzapine, amisulpride, risperidone, or aripiprazole)ExperimentalNon-clozapine users in phase 2 will be assigned to clozapine or another Second generation antipsychotics (SGAs) not previously used in phase 1 and 2.
Receives: Drug: Phase 3B: Clozapine or another SGAs

What is being measured

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

  1. Treatment efficacy rate

    A 40% reduction or more of the total score in the Positive and Negative Syndrome Scale (PANSS). The PANSS scale consists of 30 items, and each item is rated on a 7-point scale, ranging from 1 (no symptoms) to 7 (extremely severe).

    Measured: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months

  2. All-cause dropout rate

    Marked by the treatment discontinuation for any reasons, including poor efficacy, intolerance of adverse reactions, poor compliance and other reasons.

    Measured: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months

Secondary outcomes (36)

  1. Change from baseline in Clinician-Rated Dimensions of Psychosis Symptom severity (CRDPS)

    Clinician-Rated Dimensions of Psychosis Symptom severity (CRDPS). The CRDPS scale evaluates eight symptom dimensions of psychosis. Each symptom domain is rated for the past 7 days on a 5-point scale ranging from 0 (absent) to 4 (present and severe).

    Measured: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months

  2. Cost inventory

    Direct medical costs (for example, antipsychotics costs, medical examinations costs, health care and service costs and adverse events costs) and indirect costs (such as traffic, nursing, and losing of labor) of the treatments.

    Measured: baseline,2 months,4 months, 6 months and 12 months

  3. Change from baseline in Clinical Global Impression Scale-Severity (CGI-S)

    Clinical Global Impression Scale-Severity (CGI-S), including assessment of disease severity and overall efficacy. The severity of the disease was scored on an eight-point scale ranging from 0 (not rated) to 7 (extremely severe). The overall efficacy was assessed on an 8-point scale ranging from 0 (not assessed) to 7 (significant deterioration).

    Measured: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months

  4. Change from baseline in Calgary Depression Scale for Schizophrenia (CDSS)

    The Calgary Depression Scale for Schizophrenia (CDSS) consists of nine items, each scored from 0 to 3. A total score greater than 6 is considered depression.

    Measured: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months

  5. Social function

    Chinese version of UPSA-B, the UCSD (University of California,San Diego) Performance-based Skills Assessment-Brief, consists of two parts: financial skill (A and B) and communication skill. The score of financial skill A range from 0 to 5. The score of financial skill B range from 0 to 6. The score of communication skill range from 0 to 9. The higher scores mean a better outcome.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  6. Life quality: The Heinirich Quality of life Scale (HRQOL)

    The Heinirich Quality of life Scale (HRQOL) consists of 21 items, each scored from 0 to 6. The higher scores mean a better outcome.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  7. Life quality: Medication Satisfaction Questionnaire (MSN)

    Medication Satisfaction Questionnaire (MSN) has one item, scored from 1 to 7. The higher scores indicate higher satisfaction with the medication.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  8. Life quality: Subjective Well-being under Neuroleptics (SWN)

    Subjective Well-being under Neuroleptics (SWN) consists of 20 items, each scored from 1-6.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  9. Extrapyramidal adverse effects: The Barnes Akathisia Scale (BAS)

    The Barnes Akathisia Scale (BAS) will be used to evaluate objective performance and subjective experience of akathisia, scored from 0 to 3, and the overall clinical evaluation of akathisia is scored from 0 to 5. The higher scores mean a more serious side effect.

    Measured: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months

  10. Extrapyramidal adverse effects: Simpson-Angus Extrapyramidal Side Effects Scale (SAS)

    Simpson-Angus Extrapyramidal Side Effects Scale (SAS) consists of 10 items, each scored from 0 to 4. The higher scores mean a more serious side effect.

    Measured: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months

  11. Extrapyramidal adverse effects: Abnormal Involuntary Movement Scale (AIMS)

    Abnormal Involuntary Movement Scale (AIMS) consists of 12 items. The first 10 of 12 items is scored from 0 to 4, and the last 2 is scored from 0 to 1. The higher scores mean the more obvious abnormal involuntary movement.

    Measured: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months

  12. Sexual dysfunction

    Arizona Sexual Experiences Scale (ASEX) includes 5 items, each scored from 1-6. A total score greater than or equal to 19 and any item greater than or equal to 5, or any 3 items greater than or equal to 4, can help clinical diagnosis of sexual dysfunction.

    Measured: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months

  13. Change from baseline in cognitive function: MCCB

    MATRICS consensus cognitive battery (MCCB) consists of 10 tests that assess cognitive performance in 7 domains, including processing speed, attention/vigilance, working memory, verbal memory, visual learning, reasoning and problem solving, and social cognition.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  14. Change from baseline in cognitive function: NBSC

    New cognitive battery for patients with schizophrenia in China(NBSC). NBSC includes 4 tests from MCCB and 5 new tests (Trial making A, BACS, HVLT-R learning and recall, CPTIP, dominant hand Grooved Pegboard, Color Trails I and II, PASAT)

    Measured: baseline,2 months,4 months and 6 months and 12 months

  15. Safety index: Blood pressure

    Blood pressure in mmHg

    Measured: baseline,2 months,4 months and 6 months and 12 months

  16. Safety index: Heart rate

    Heart rate

    Measured: baseline,2 months,4 months and 6 months and 12 months

  17. Safety index: Respiratory rate

    respiratory rate

    Measured: baseline,2 months,4 months and 6 months and 12 months

  18. Safety index: Vital signs

    body temperature in celsius

    Measured: baseline,2 months,4 months and 6 months and 12 months

  19. Safety index: Blood count

    Blood count

    Measured: baseline,2 months,4 months and 6 months and 12 months

  20. Safety index: Liver function

    *Concentration of ALT, AST, GGT, ALP, TB, and DB.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  21. Safety index: renal function

    *Concentration of serum creatinine, blood urea nitrogen, uric acid, serum cystatin C, homocysteine.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  22. Safety index: thyroid function

    Thyroid function related hormone levels will be tested, including FT3, FT4, T3, TSH, and T4.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  23. Safety index: prolactin

    Serum prolactin level

    Measured: baseline,2 months,4 months and 6 months and 12 months

  24. Safety index: QTc interval

    QTc interval

    Measured: baseline,2 months,4 months and 6 months and 12 months

  25. Metabolic side effects: body weight

    Weight in kilograms

    Measured: baseline,2 months,4 months and 6 months and 12 months

  26. Metabolic side effects: BMI

    BMI in kg/m^2

    Measured: baseline,2 months,4 months and 6 months and 12 months

  27. Metabolic side effects: waist circumstance

    Waist circumstance in centimeter

    Measured: baseline,2 months,4 months and 6 months and 12 months

  28. Metabolic side effects: fasting blood-glucose

    Fasting blood-glucose

    Measured: baseline,2 months,4 months and 6 months and 12 months

  29. Metabolic side effects: insulin index

    Insulin resistance was assessed using homeostasis model assessment (HOMA-IR).

    Measured: baseline,2 months,4 months and 6 months and 12 months

  30. Metabolic side effects: serum lipid level

    Concentration of serum triglyceride, LDL-C(low density lipoprotein cholesterol), HDL-C(high density lipoprotein cholesterol) and apolipoprotein.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  31. Metabolic side effects: assessment of feeding behavior

    Three-Factor Eating Questionnaire (TFEQ-21) consists of 21 items, including 3 dimensions (non-controlled eating, cognitively restricted eating, and emotional eating). Each item is scored from 1 to 4, and the first 16 item requires reverse scoring before calculating dimension scores. The higher scores mean a higher tendency for non-controlled eating, cognitively restricted eating, and emotional eating.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  32. Metabolic side effects: Visual Analogue Scale (VAS)

    Visual Analogue Scale (VAS) was used to evaluate the desire to eat, hunger sensation and willingness to eat. The scale consists of 3 items, each scored from 0 to 10. The higher scores mean a stronger desire to eat, hunger sensation and willingness to eat.

    Measured: baseline,2 months,4 months and 6 months and 12 months

  33. Metabolic side effects: Physical Activity Evaluation

    Physical Activity Evaluation

    Measured: baseline,2 months,4 months and 6 months and 12 months

  34. MRI examinaitons

    Change of grey matter volume and functional connectivity in certain brain region was focused in the MRI examinations, to evaluate the ability of MRI examinaitons (structural MRI, functional MRI and Magnetic Resonance Spectroscopy) to predict response to antipsychotic treatment in first-episode schizophrenia.

    Measured: baseline,2 months and 4 months

  35. Pharmacogenomics

    *Blood sample was collected and genes related to drug efficacy and adverse reaction were tested to evaluate the ability of pharmacogenomics to predict response to antipsychotic treatment in first-episode schizophrenia.

    Measured: baseline,2 months,4 months

  36. Lipidomics

    *Serum sample was collected for lipidomic analysis to investigate correlation between serum lipids and rapid weight gain in first-episode schizophrenia.

    Measured: baseline,2 months,4 months

Timeline

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

  1. First posted27 Apr 2018
  2. Study start12 Feb 2019
  3. Primary completion27 Sep 2023
  4. Study completion27 Sep 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
The sequential multiple assignment randomized trial design (SMART) design is based on the combination of sequential therapy and dynamic therapy, which is more suitable to assess the effectiveness of treatment options in the real world setting. Participants who had an acceptable response to the randomly assigned drug therapy will remain on that treatment for a 12-month treatment period, while non-responders will move to the next phase of the study to receive a new treatment.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
762 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510325
Sponsor's protocol ID
CRC2017ZD03
Status last verified
Aug 2023
First submitted
12 Feb 2018
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li X, Lu C, Zhai Z, Smith RC, Zhang S, Wang H, Wang C, Yao Z, Chen Z, Xu X, Xie S, Feng T, Gao T, Dong Y, Zhuo K, Xiang Q, Jin H, Davis JM, Jiang K, Xu Y, Leucht S, Liu D. Clozapine After 1 Failed Antipsychotic Drug Trial in First-Episode Psychosis: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Jun 1;83(6):570-580. doi: 10.1001/jamapsychiatry.2026.0086.

    PubMed 41811299

  • Li X, Guo X, Fan X, Feng T, Wang C, Yao Z, Xu X, Chen Z, Wang H, Xie S, He J, Zhuo K, Xiang Q, Cen H, Wang J, Smith RC, Jin H, Keshavan MS, Marder SR, Davis JM, Jiang K, Xu Y, Liu D. Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments (SMART-CAT) in first-episode schizophrenia patients: Rationale and trial design. Schizophr Res. 2021 Apr;230:87-94. doi: 10.1016/j.schres.2020.11.010. Epub 2020 Dec 2.

    PubMed 33279374

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Phase 1: Olanzapine, Phase 1: Risperidone and Phase 1: Amisulpride in people with Schizophrenia, run by Shanghai Mental Health Center at 7 sites 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 7 inclusion and 4 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Treatment efficacy rate (time frame: baseline,0.5 months,1 months, 2 months,4 months , 6 months , 8 months and 12 months). 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 NCT03510325, which also lists 2 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 8 Apr 2025.

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