PsychosisPhase 4NCT06546475
A Pilot Trial of Tapering Antipsychotics for Patients in Remitted Psychosis Co-administering With N-Acetylcysteine
A Phase 4 study testing N-Acetylcysteine in people with Psychosis, run by National Taiwan University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychosis
- What is being tested?
- N-Acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tapering Antipsychotics in Patients With Remitted Psychosis: From Bedside to Bench Employing Animal Model and N-Acetylcysteine Study and Back to Bedside
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
Read the 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 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%.
- Conditions
- Psychosis
- Being tested
- N-Acetylcysteine
- Keywords
- antipsychotic, N-Acetylcysteine, pilot trial, psychosis, relapse, remission, schizophrenia, tapering
- Medical subject headings
- Psychotic Disorders, Recurrence, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDrug
Also called N-Acetylcysteine 2400 mg/d
regular dose or high dose add-on
| Study group | Role | What they receive |
|---|---|---|
| NAC add-on 1 | Experimental | NAC add-on with 1200 mg/d Receives: Drug: N-Acetylcysteine |
| NAC add-on 2 | Active comparator | NAC add-on with 2400 mg/d Receives: Drug: N-Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (6)
Extent of dose reduction (%)
The percentage of doses reduced at a designated time point will be calculated by the formula: [1- (current dose)/(baseline dose)]x100%
Measured: 1 year
Clinical severity: symptoms
Positive and Negative Syndrome Scale (PANSS) (1 to 7, 1: normal; 7: profound severity)
Measured: 1 year
Clinical severity: global
Clinical Global Impression of Severity (CGI-S) (1 to 7, 1: no illness; 7: most severe)
Measured: 1 year
Personal and Social Functioning
Personal and Social Performance scale (PSP) (0-100, worst to best)
Measured: 1 year
Self-report of subjective wellbeing
EuroQoL-5D visual analogue scale (EQ-5D-VAS) (0-100, worst to best)
Measured: 1 year
Self-report of Quality of Life
Mandarin Chinese version of the WHOQOL-BREF (1~5, 1: very dissatisfied; 5: very satisfied)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen-Chung Liu, MD, PhD, Principal investigator, National Taiwan University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546475
- Sponsor's protocol ID
- 202401210MIND
- Other IDs
- NSTC 113-2314-B-002-184-MY3
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tapering Antipsychotics in Patients With Remitted Psychosis: From Bedside to Bench Employing Animal Model and N-Acetylcysteine Study and Back to Bedside
- ClinicalTrials.gov ID
- NCT06546475
- Acronym / sponsor ID
- 202401210MIND
- Conditions
- Psychosis
- Keywords
- antipsychotic, N-Acetylcysteine, pilot trial, psychosis, relapse, remission, schizophrenia, tapering
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC add-on 1 | Experimental | Drug: N-AcetylcysteineNAC add-on with 1200 mg/d |
| NAC add-on 2 | Active comparator | Drug: N-AcetylcysteineNAC add-on with 2400 mg/d |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-AcetylcysteineAlso: N-Acetylcysteine 2400 mg/dregular dose or high dose add-on | Drug | NAC add-on 1, NAC add-on 2 |
Primary outcome
Relapse rate (%)
Time frame: 1 year
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
6 secondary outcomes
Extent of dose reduction (%)
Time frame: 1 year
Clinical severity: symptoms
Time frame: 1 year
Clinical severity: global
Time frame: 1 year
Personal and Social Functioning
Time frame: 1 year
Self-report of subjective wellbeing
Time frame: 1 year
Self-report of Quality of Life
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chen-Chung Liu, MD, PhD principal investigator
National Taiwan University, College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-Acetylcysteine in people with Psychosis, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen-Chung Liu, MD, PhD (0972651756, chchliu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (%) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.