Schizophrenia, Treatment-ResistantAmisulprideTRSNCT05956600
An Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Amisulpride in Treating Patients With Schizophrenia and Schizoaffective Disorder Who Have Treatment-Resistant Positive Symptoms
A study testing Amisulpride 50 MG in people with Schizophrenia, Treatment-Resistant, run by University of California, Los Angeles.
Trial summary
The objectives of this study are to evaluate the safety and efficacy of Amisulpride as an add-on therapy or alternative monotherapy in treating patients with schizophrenia or schizoaffective disorder who have treatment-resistant positive symptoms and who are not eligible for treatment with clozapine due to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Treatment-Resistant
- What is being tested?
- Amisulpride 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jan 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Signed and dated written informed consent. 2. Age 18-65 years 3. Male or female*. 4. *For participants assigned female sex at birth: A participant is eligible to participate if not pregnant, and one of the following conditions applies: (1) Is not able to become pregnant; (2) is a person able to be pregnant (PABP) and using a contraceptive method that is highly effective, with a failure rate of <1%.
- 5. Diagnosis of schizophrenia or schizoaffective disorder according to DSM-V criteria 6. Treatment-resistant positive symptoms defined by subjects receiving an antipsychotic but continuing to score 4 or greater one of the following Positive and Negative Syndrome Scale (PANSS) items: P1 (delusions), P3 (hallucinations), P6 (suspiciousness or persecution), or G9 (unusual thought content).
- 7. Subjects receiving clozapine will also be included if there is a concern that the side effect burden from clozapine has led the clinician and the patient to consider changing to another medication.
- 8. English-speaking. 9. Subjects only partially responsive to other antipsychotics will also be included.
- 10. Non-suicidal self-injurious behavior may be included if approved by the study clinician.
- 11. Able to provide informed consent.
Who cannot join
- Diagnosis of any other psychiatric disorder.
- History of intolerance or allergy to amisulpride.
- Known history of severe cardiac arrhythmia or prolonged QT interval.
- Concomitant use of medications that may interact with amisulpride or prolong QT interval (see section 4.3, "Concomitant Therapy").
- Lactating patients, patients with prolactin-dependent tumors, and patients with breast cancer will be excluded.
- Patients with laboratory- and/or imaging-confirmed pheochromocytoma will be excluded.
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- Columbia-Suicide Severity Rating Scale:
- Suicidal ideation score of 4 or greater within the last month of the assessment at a frequency of once a week or more.
- Suicidal ideation score of 5 within the last 6 months of the assessment.
- Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment.
- Current moderate or severe alcohol and substance use disorders, which could pose a safety concern or interfere with the therapeutic process.
- Existing relevant physical health problems: such as cardiovascular disease, previous problems with prolactin, impaired liver/renal function or epilepsy.
- Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
- Planning to start a new drug, diet, or behavioral intervention during the study.
- A previous trial of amisulpride.
- Unable to perform or cooperate with study requirements.
About this study
The objectives of this study are to evaluate the safety and efficacy of Amisulpride as an add-on therapy or alternative monotherapy in treating patients with schizophrenia or schizoaffective disorder who have treatment-resistant positive symptoms and who are not eligible for treatment with clozapine due to intolerance, failure from a prior clozapine trial, or unwillingness to be treated with clozapine.
Read the detailed description
Prior to enrollment, eligible patients and their treating psychiatrist will decide whether the goal is to evaluate amisulpride as an antipsychotic that is added to the current medication or as an alternative monotherapy. All study participants will receive amisulpride in oral form.
For monotherapy patients, after primary and secondary endpoints are recorded, the study psychiatrist will begin a gradual cross-taper of the patient's current antipsychotic medication to amisulpride. The goal will be to have the patient on monotherapy by the one-month rating. The dose of amisulpride will vary depending on whether amisulpride will be used as an add-on therapy or monotherapy. The starting dose of amisulpride will be 50 mg/day and will be increased in 50 mg increments every 2-3 days until the optimal dose is reached, as determined by the treating psychiatrist, with a maximum dose of 1,200 mg/day.
- Conditions
- Schizophrenia, Treatment-Resistant
- Being tested
- Amisulpride 50 MG
- Keywords
- Schizophrenia, Schizoaffective Disorder, Amisulpride
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amisulpride 50 MGDrug
Amisulpride 50 mg titrated to dose range of 50 to 1200 mg
| Study group | Role | What they receive |
|---|---|---|
| Amisulpride | Other | Amisulpride administered orally. Dose range 50 to 1200 mg daily Receives: Drug: Amisulpride 50 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale
Change in Total Score
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Action of PI. Loss of sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia, Treatment-ResistantStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Arm Administration of Amisulpride
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- PoloMar Health LLC
- Responsible party
- Principal investigator, Stephen R. Marder, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956600
- Sponsor's protocol ID
- AMI 1
- Acronym
- AmisulprideTRS
- Status last verified
- Jun 2024
- First submitted
- 13 Jul 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Amisulpride in Treating Patients With Schizophrenia and Schizoaffective Disorder Who Have Treatment-Resistant Positive Symptoms
- ClinicalTrials.gov ID
- NCT05956600
- Acronym / sponsor ID
- AmisulprideTRS / AMI 1
- Conditions
- Schizophrenia, Treatment-Resistant
- Keywords
- Schizophrenia, Schizoaffective Disorder, Amisulpride
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Action of PI. Loss of sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- PoloMar Health LLC
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Jul 2023 (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 objectives of this study are to evaluate the safety and efficacy of Amisulpride as an add-on therapy or alternative monotherapy in treating patients with schizophrenia or schizoaffective disorder who have treatment-resistant positive symptoms and who are not eligible for treatment with clozapine due to intolerance, failure from a prior clozapine trial, or unwillingness to be treated with clozapine.
Detailed description
Prior to enrollment, eligible patients and their treating psychiatrist will decide whether the goal is to evaluate amisulpride as an antipsychotic that is added to the current medication or as an alternative monotherapy. All study participants will receive amisulpride in oral form.
For monotherapy patients, after primary and secondary endpoints are recorded, the study psychiatrist will begin a gradual cross-taper of the patient's current antipsychotic medication to amisulpride. The goal will be to have the patient on monotherapy by the one-month rating. The dose of amisulpride will vary depending on whether amisulpride will be used as an add-on therapy or monotherapy. The starting dose of amisulpride will be 50 mg/day and will be increased in 50 mg increments every 2-3 days until the optimal dose is reached, as determined by the treating psychiatrist, with a maximum dose of 1,200 mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Arm Administration of Amisulpride
| Arm | Type | Receives |
|---|---|---|
| Amisulpride | Other | Drug: Amisulpride 50 MGAmisulpride administered orally. Dose range 50 to 1200 mg daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Signed and dated written informed consent. 2. Age 18-65 years 3. Male or female*. 4. *For participants assigned female sex at birth: A participant is eligible to participate if not pregnant, and one of the following conditions applies: (1) Is not able to become pregnant; (2) is a person able to be pregnant (PABP) and using a contraceptive method that is highly effective, with a failure rate of <1%.
- 5. Diagnosis of schizophrenia or schizoaffective disorder according to DSM-V criteria 6. Treatment-resistant positive symptoms defined by subjects receiving an antipsychotic but continuing to score 4 or greater one of the following Positive and Negative Syndrome Scale (PANSS) items: P1 (delusions), P3 (hallucinations), P6 (suspiciousness or persecution), or G9 (unusual thought content).
- 7. Subjects receiving clozapine will also be included if there is a concern that the side effect burden from clozapine has led the clinician and the patient to consider changing to another medication.
- 8. English-speaking. 9. Subjects only partially responsive to other antipsychotics will also be included.
- 10. Non-suicidal self-injurious behavior may be included if approved by the study clinician.
Key exclusion criteria (16 listed)
- Diagnosis of any other psychiatric disorder.
- History of intolerance or allergy to amisulpride.
- Known history of severe cardiac arrhythmia or prolonged QT interval.
- Concomitant use of medications that may interact with amisulpride or prolong QT interval (see section 4.3, "Concomitant Therapy").
- Lactating patients, patients with prolactin-dependent tumors, and patients with breast cancer will be excluded.
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 |
|---|---|---|
| Amisulpride 50 MGAmisulpride 50 mg titrated to dose range of 50 to 1200 mg | Drug | Amisulpride |
Primary outcome
Positive and Negative Symptom Scale
Time frame: Baseline to 12 months
Change in Total Score
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Amisulpride 50 MG in people with Schizophrenia, Treatment-Resistant, run by University of California, Los Angeles.
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Positive and Negative Symptom Scale (time frame: Baseline to 12 months). 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 24 Jun 2024.