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| ID | Type | Description | Link |
|---|---|---|---|
| NSTC 113-2314-B-002-184-MY3 | Other Grant/Funding Number | National Science and Technology Council (NSTC), Taiwan |
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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
Trial procedure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC add-on 1 | Experimental | NAC add-on with 1200 mg/d |
|
| NAC add-on 2 | Active Comparator | NAC add-on with 2400 mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetylcysteine | Drug | regular dose or high dose add-on |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 1 year |
| Clinical severity: symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative measurements by semi-structured interview | At each time point of shared decision-making regarding whether to taper down dose or not, we will conduct a semi-structure interview to explore patient's key considerations, such as psychosocial issues, soundness of supportive system, and self-assessed risk of relapse, which prompt the patient to feel comfortable about continuing tapering, or to halt at current dose for a longer term. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen-Chung Liu, MD, PhD | Contact | 0972651756 | chchliu@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chen-Chung Liu, MD, PhD | National Taiwan University, College of Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012008 | Recurrence |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Positive and Negative Syndrome Scale (PANSS) (1 to 7, 1: normal; 7: profound severity)
| 1 year |
| Clinical severity: global | Clinical Global Impression of Severity (CGI-S) (1 to 7, 1: no illness; 7: most severe) | 1 year |
| Personal and Social Functioning | Personal and Social Performance scale (PSP) (0-100, worst to best) | 1 year |
| Self-report of subjective wellbeing | EuroQoL-5D visual analogue scale (EQ-5D-VAS) (0-100, worst to best) | 1 year |
| Self-report of Quality of Life | Mandarin Chinese version of the WHOQOL-BREF (1~5, 1: very dissatisfied; 5: very satisfied) | 1 year |
| 1 year |
| Self-report of Medication Adherence | 5-point Likert scale for medication adherence (1: < 20%; 2: 20~40%; 3: 40~60%; 4: 60~80%; 5: > 80%) | 1 year |
| Self-report of Medication Satisfaction | 7-point Likert scale for medication satisfaction (1: most dissatisfied; 7: most satisfied) | 1 year |
| Adverse events | checklist of Udvalg for Kliniske Undersogelser (UKU) Side-effects Rating Scale | 1 year |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |