SchizophreniaPhase 3NCT06799559
Study on the Efficacy and Safety of QLM1016 in Schizophrenia
A Phase 3 study testing 3-6mg QLM1016 and 10-20 mg Aripiprazole oral solution film in people with Schizophrenia, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- 3-6mg QLM1016 and 10-20 mg Aripiprazole oral solution film
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteChina
- Study dates
- 2 Oct 2025to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female subjects, ages 18-65 inclusive, with a clinical diagnosis of schizophrenia
- PANSS total score ≥ 70 and ≤ 120，Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behavior, conceptual disorganization, and unusual thought content
- CGI-S score ≥ 4
Who cannot join
- Currently, meet DSM-5 diagnostic criteria for other psychiatric disorders ( for example schizoaffective disorder, schizophreniform disorder, bipolar I and II disorder; pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders；
- known or suspected borderline or antisocial personality disorder or other psychiatric disorders of sufficient severity to interfere with participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Controlled Study on the Efficacy and Safety of QLM1016 in the Treatment of Schizophrenia
The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- 3-6mg QLM1016, 10-20 mg Aripiprazole oral solution film
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-6mg QLM1016Drug
3-6mg QLM1016 pluse Aripiprazole dummy oral solution film administered orally once daily for 6 weeks
10-20 mg Aripiprazole oral solution filmDrug
10-20mg Aripiprazole oral solution film plus QLM1016 dummy oral solution film administered orally once daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| QLM1016 | Experimental | Not described Receives: Drug: 3-6mg QLM1016 |
| Aripiprazole oral solution film | Active comparator | Not described Receives: Drug: 10-20 mg Aripiprazole oral solution film |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score
Measured: Time Frame: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start2 Oct 2025
- Primary completion23 Oct 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Qilu Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799559
- Sponsor's protocol ID
- QLM1016-301
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2025
- Last updated
- 14 Oct 2026
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Controlled Study on the Efficacy and Safety of QLM1016 in the Treatment of Schizophrenia
- ClinicalTrials.gov ID
- NCT06799559
- Acronym / sponsor ID
- QLM1016-301
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jan 2025 (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.
The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLM1016 | Experimental | Drug: 3-6mg QLM1016 |
| Aripiprazole oral solution film | Active comparator | Drug: 10-20 mg Aripiprazole oral solution film |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female subjects, ages 18-65 inclusive, with a clinical diagnosis of schizophrenia
- PANSS total score ≥ 70 and ≤ 120，Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behavior, conceptual disorganization, and unusual thought content
- CGI-S score ≥ 4
Key exclusion criteria (2 listed)
- Currently, meet DSM-5 diagnostic criteria for other psychiatric disorders ( for example schizoaffective disorder, schizophreniform disorder, bipolar I and II disorder; pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders；
- known or suspected borderline or antisocial personality disorder or other psychiatric disorders of sufficient severity to interfere with participation in the study
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 |
|---|---|---|
| 3-6mg QLM10163-6mg QLM1016 pluse Aripiprazole dummy oral solution film administered orally once daily for 6 weeks | Drug | QLM1016 |
| 10-20 mg Aripiprazole oral solution film10-20mg Aripiprazole oral solution film plus QLM1016 dummy oral solution film administered orally once daily for 6 weeks. | Drug | Aripiprazole oral solution film |
Primary outcome
change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Time Frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3-6mg QLM1016 and 10-20 mg Aripiprazole oral solution film in people with Schizophrenia, run by Qilu Pharmaceutical Co., Ltd. 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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 to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score (time frame: Time Frame: 6 weeks). 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 14 Oct 2026.