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

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National Taiwan University

Status and phase

Not yet enrolling
Phase 4

Conditions

Psychosis

Treatments

Drug: N-Acetylcysteine

Study type

Interventional

Funder types

Other

Identifiers

NCT06546475
NSTC 113-2314-B-002-184-MY3 (Other Grant/Funding Number)
202401210MIND

Details and patient eligibility

About

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

Full 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 dose, and a shared decision-making process during tapering. Pre-treatment of NAC 1200 mg/d will be given for 1-2 weeks and then titrated up to 2400 mg/d to test tolerability. Patients will stay at either dose throughout the remaining of the course as preferable.
  • Dose tapering schedule: In the beginning, no more than one-quarter of the baseline antipsychotic dose will be reduced at a time. Patients need to be monitored every 4 weeks (or 1 month) by phone or in person. If they can maintain stabilized for 12 weeks (or 3 months) in a reduced dose, they can take next tapering of no more than one quarter of their current dose again, yielding 9/16 (3/4x3/4) of baseline dose. The subsequent dose reduction will be a reiteration of the previous step, cutting off one-quarter of the current dose following the formula (3/4) powered by n, rather than cutting off another 1/4 of the initial dose. The processes will be reiterated for 4 steps for one year.
  • Conditions during tapering: Noteworthily, when the patient is eligible to consider next dose reduction, he or she is empowered to take shared decision-making as they might opt to stay at their current dose for a more extended time for any reason. Patients can reach the study team during the course whenever they felt unsure if any relapse sign might be re-emerging. As needed use of benzodiazepines or hypnotics will be allowed to help control suspected signs of relapse. Patients will be supervised to stay at current dose for a longer term or even re-escalate to previous higher dose if any sign of suspected relapse re-emerges, and then will be closely monitored if their symptoms can be stabilized within 2 weeks.
  • Defining relapse: 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.
  • Practicability of dosing: The actual dose taken would not always be precisely the number calculated by the formula (3/4)n, as it was impractical to cut off a quarter or even smaller piece of a tablet for daily dosing. Several versions of intermittent or irregular dosing schedules have been generated to meet the needs.
  • Extent of dose reduction: The percentage of doses reduced at a designated time point will be calculated by the following formula: [1- (current dose)/(baseline dose)]x100%.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Both male and female outpatients or patients at psychiatric daycare service
  2. Age 18-60 years old at the time of screening
  3. A diagnosis of schizophrenia, schizophreniform disorder, psychosis NOS, based on the DSM-5 criteria
  4. 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
  5. 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
  6. Currently receiving antipsychotic treatment at a fixed dose for at least 3 months, including long-acting injectable antipsychotic
  7. No revised use of benzodiazepines, antidepressants, anticholinergics, or other concomitant medications during the past 3 months

Exclusion criteria

  1. A score of 5 or more on any of the 30 PANSS rating items at screening
  2. Admission to the acute psychiatric unit during the past 6 months
  3. A change in dose of current antipsychotic medication in recent 3 months
  4. Concomitant use of mood stabilizers, such as lithium, valproic acid, or other anti-epileptic drugs
  5. Mental retardation known as IQ below 70 prior to the diagnosis of schizophrenia
  6. A history of pervasive mental disorder or bipolar disorder
  7. A medical condition with significant cognitive sequelae
  8. A history of substance dependence during the past 6 months
  9. Currently in pregnancy or breastfeeding
  10. A history of allergy to N-Acetylcysteine
  11. Patient with phenylketonuria ( because the Actein Effervescent Tablet 600 mg/tab contains aspartame)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

NAC add-on 1
Experimental group
Description:
NAC add-on with 1200 mg/d
Treatment:
Drug: N-Acetylcysteine
NAC add-on 2
Active Comparator group
Description:
NAC add-on with 2400 mg/d
Treatment:
Drug: N-Acetylcysteine

Trial contacts and locations

0

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Central trial contact

Chen-Chung Liu, MD, PhD

Data sourced from clinicaltrials.gov

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