A Pilot Trial of Tapering Antipsychotics for Patients in Remitted Psychosis Co-administering With N-Acetylcysteine

NCT06546475 | Not Yet Recruiting Phase 4

• 2 other identifiers: 202401210MINDNSTC 113-2314-B-002-184-MY3
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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 of stabilization to 3 months (compared to the 6 months prerequisite of a previous Guided Antipsychotic Reduction to Minimum Effective Dose (GARMED) trial,) smoothly, without increased risk of relapse or frequency of adverse events compared to the 2-year results of the GARMED trial

Conditions

Psychosis

Keywords

antipsychotic; N-Acetylcysteine; pilot trial; psychosis; relapse; remission; schizophrenia; tapering

Outcome Measures

Primary Outcomes (1)

• Relapse rate (%)

  If a patient's recurrent psychotic symptoms cannot be controlled (any PANSS score \> 3 in P1, P2, P3, G5, or G9) within 2 weeks under an antipsychotic dose equal to their baseline dose, the patient will be designated as having a relapse

  1 year

Secondary Outcomes (6)

• Extent of dose reduction (%)

  1 year

• Clinical severity: symptoms

  1 year

• Clinical severity: global

  1 year

• Personal and Social Functioning

  1 year

• Self-report of subjective wellbeing

  1 year

Other Outcomes (4)

• Qualitative measurements by semi-structured interview

  1 year

• Self-report of Medication Adherence

  1 year

• Self-report of Medication Satisfaction

  1 year

Study Arms (2)

NAC add-on 1

EXPERIMENTAL

NAC add-on with 1200 mg/d

Drug: N-Acetylcysteine

NAC add-on 2

ACTIVE COMPARATOR

NAC add-on with 2400 mg/d

Drug: N-Acetylcysteine

Interventions

N-Acetylcysteine DRUG

regular dose or high dose add-on

Also known as: N-Acetylcysteine 2400 mg/d

NAC add-on 1; NAC add-on 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Psychotic Disorders; Recurrence; Schizophrenia

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Chen-Chung Liu, MD, PhD

  National Taiwan University, College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Chung Liu, MD, PhD

CONTACT

0972651756; chchliu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share