Guided Dose Reduction of Antipsychotic in Patients With Psychosis in Remitted States (GDR)
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|ClinicalTrials.gov Identifier: NCT03248180|
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Impact of Guided Antipsychotic Dose Reduction in Patients With Psychosis Under Remitted States: a Randomized Control Trial and Prospective Follow-up Study|
|Actual Study Start Date :||July 24, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Guided dose reduction (GDR)
Patients in the GDR group will be advised to reduce < 25% of their current dose of antipsychotic agents estimated on a weekly base and follow-up every 4 weeks for at least 12 weeks.
Maintenance treatment group (MTG)
Patients in the MTG will be advised to stay on their current dose of antipsychotics throughout the observational period, follow-up every 12 weeks.
- Relapse of psychosis defined by worsening of scores in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: up to 2 years ]Patients will be measured with a Positive and Negative Syndrome Scale (PANSS) every 4 weeks for 3 times (during 12 weeks) if conducting dose reduction or every 12 weeks if staying on the same dose to observe if any worsening of symptoms. Patient has a PANSS score > 4 in any item of those 3 positive symptoms (P1: delusion, P2: conceptual disorganization, P3: hallucination) and 2 general symptoms (G9: unusual thought, G5:mannerism and posturing) during observational period for more than 1 week will be recognized as having a relapse of psychosis.
- Personal Social Performance (PSP) scores [ Time Frame: up to 2 years ]Patients will be rated by their attending psychiatrists with PSP scale to evaluate their functioning in 4 aspects of life, including socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviors as to give a summary score at baseline and annually
- quality of life (Euro-5D VAS) [ Time Frame: up to 2 years ]Patients report their quality of life using a 20-cm visual analogue at baseline and annually.
- severity of extrapyramidal symptoms [ Time Frame: up to 2 years ]Patient's severity of extrapyramidal symptoms will be rated by their psychiatrists using Simpson-Angus Scale, the Abnormal Involuntary Movement Scale, and the Barnes Akathisia Rating Scale at each visit.
- medication satisfaction questionnaire (MSQ) [ Time Frame: up to 2 years ]Patients will be asked to fill a self-rated 7-point Likert scale for medication satisfaction at baseline and annually.
- neurocognitive functioning [ Time Frame: up to 2 years ]Patients will be assessed with the module for schizophrenia of the Cambridge Neuropsychological Test Automatic Battery (Cantab) at baseline and at the exit of the study.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248180
|Contact: Chen-Chung Liu, MD, PhD||886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Chen-Chung Liu, MD, PhD 886-2-23123456 ext 66130 email@example.com|
|Principal Investigator:||Chen-Chung Liu, MD, PhD||National Taiwan University Hospital|