Status:
NOT_YET_RECRUITING
A Pilot Trial of Tapering Antipsychotics for Patients in Remitted Psychosis Co-administering With N-Acetylcysteine
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Psychosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The investigators are going to observe if add-on of n-acetylcysteine (NAC) 1200 or 2400 mg/d during tapering of antipsychotics in patients with remitted psychosis can help to reduce the pre-requisite ...
Detailed Description
Trial procedure * Pretreatment: more instructions were delivered regarding the extent and the tempo of dose reduction, warning signal of relapse, timing to call for help if in need to resume rescue d...
Eligibility Criteria
Inclusion
- Both male and female outpatients or patients at psychiatric daycare service
- Age 18-60 years old at the time of screening
- A diagnosis of schizophrenia, schizophreniform disorder, psychosis NOS, based on the DSM-5 criteria
- With a Positive and Negative Syndrome Scale (PANSS), score \< 3 in all 3 positive symptoms (P1: delusion, P2: conceptual disorganization, P3: hallucination) and 2 general symptoms (G9: unusual thought, G5: mannerism and posturing) for at least 3 months
- With a PANSS score \< 4 in all 3 negative symptoms (N1: blunted affect, N4: social withdrawal, N6: lack of spontaneity/flow in conversation) for at least 3 months
- Currently receiving antipsychotic treatment at a fixed dose for at least 3 months, including long-acting injectable antipsychotic
- No revised use of benzodiazepines, antidepressants, anticholinergics, or other concomitant medications during the past 3 months
Exclusion
- A score of 5 or more on any of the 30 PANSS rating items at screening
- Admission to the acute psychiatric unit during the past 6 months
- A change in dose of current antipsychotic medication in recent 3 months
- Concomitant use of mood stabilizers, such as lithium, valproic acid, or other anti-epileptic drugs
- Mental retardation known as IQ below 70 prior to the diagnosis of schizophrenia
- A history of pervasive mental disorder or bipolar disorder
- A medical condition with significant cognitive sequelae
- A history of substance dependence during the past 6 months
- Currently in pregnancy or breastfeeding
- A history of allergy to N-Acetylcysteine
- Patient with phenylketonuria ( because the Actein Effervescent Tablet 600 mg/tab contains aspartame)
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06546475
Start Date
August 1 2024
End Date
July 31 2027
Last Update
August 9 2024
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