Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546475
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
A Pilot Trial of Tapering Antipsychotics for Patients in Remitted Psychosis Co-administering With N-Acetylcysteine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tapering Antipsychotics in Patients With Remitted Psychosis From Bedside to Bench Employing Animal Model and N-Acetylcysteine Study and Back to Bedside
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are going to observe if add-on of n-acetylcysteine NAC 1200 or 2400 mgd 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 mgd will be given for 1-2 weeks and then titrated up to 2400 mgd 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 916 34x34 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 34 powered by n rather than cutting off another 14 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 patients 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 34n 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 dosebaseline dosex100
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 mgd will be given for 1-2 weeks and then titrated up to 2400 mgd 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 916 34x34 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 34 powered by n rather than cutting off another 14 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 patients 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 34n 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 dosebaseline dosex100
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None