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 (AmisulprideTRS)

June 20, 2024 updated by: Stephen R. Marder, University of California, Los Angeles
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Diagnosis of any other psychiatric disorder.
  2. History of intolerance or allergy to amisulpride.
  3. Known history of severe cardiac arrhythmia or prolonged QT interval.
  4. Concomitant use of medications that may interact with amisulpride or prolong QT interval (see section 4.3, "Concomitant Therapy").
  5. Lactating patients, patients with prolactin-dependent tumors, and patients with breast cancer will be excluded.
  6. Patients with laboratory- and/or imaging-confirmed pheochromocytoma will be excluded.

  7. 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.
  8. Current moderate or severe alcohol and substance use disorders, which could pose a safety concern or interfere with the therapeutic process.
  9. Existing relevant physical health problems: such as cardiovascular disease, previous problems with prolactin, impaired liver/renal function or epilepsy.
  10. Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
  11. Planning to start a new drug, diet, or behavioral intervention during the study.
  12. A previous trial of amisulpride.
  13. Unable to perform or cooperate with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Amisulpride
Amisulpride administered orally. Dose range 50 to 1200 mg daily
Drug: Amisulpride 50 MG
Amisulpride 50 mg titrated to dose range of 50 to 1200 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Symptom Scale
Time Frame: Baseline to 12 months
Change in Total Score
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

PoloMar Health LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMI 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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