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

Prior treatment

• Existing relevant physical health problems: such as cardiovascular disease, previous problems with prolactin, impaired liver/renal function or epilepsy.
• Planning to start a new drug, diet, or behavioral intervention during the study.
• A previous trial of amisulpride.

Other illness

• Diagnosis of any other psychiatric disorder.
• History of intolerance or allergy to amisulpride.
• Lactating patients, patients with prolactin-dependent tumors, and patients with breast cancer will be excluded.
• Current moderate or severe alcohol and substance use disorders, which could pose a safety concern or interfere with the therapeutic process.
• Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.

Lab values

• 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").
• Patients with laboratory- and/or imaging-confirmed pheochromocytoma will be excluded.

Other

• 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.
• Unable to perform or cooperate with study requirements.

• 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%.
  • 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).
  • 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.
  • English-speaking. 9. Subjects only partially responsive to other antipsychotics will also be included.
  • Non-suicidal self-injurious behavior may be included if approved by the study clinician.
  • Able to provide informed consent.