Guided Dose Reduction of Antipsychotic in Patients With Psychosis in Remitted States

NCT03248180 | Unknown

• 1 other identifier: 201703002MIND
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

A 2-year prospective observational study comparing a group of patients in remitted states of psychosis undergoing guided antipsychotic dose reduction to a similar group of patients under maintenance antipsychotic treatment with the main outcome of interest that if the rates of relapse of psychosis between these two groups will be different.

Conditions

Psychosis; Remission

Keywords

antipsychotic; guided dose reduction; maintenance treatment; remitted psychosis; relapse

Outcome Measures

Primary Outcomes (1)

• Relapse of psychosis defined by worsening of scores in Positive and Negative Syndrome Scale (PANSS)

  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.

  up to 2 years

Secondary Outcomes (5)

• Personal Social Performance (PSP) scores

  up to 2 years

• quality of life (Euro-5D VAS)

  up to 2 years

• severity of extrapyramidal symptoms

  up to 2 years

• medication satisfaction questionnaire (MSQ)

  up to 2 years

• neurocognitive functioning

  up to 2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients received follow-up at or referred to the study hospital

You may qualify if:

• 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
• A second antipsychotic agent only used for a low-dose, as needed adjuvant purpose
• No revised use of benzodiazepines, antidepressants, anticholinergics, or other concomitant medications during past 3 months -

You may not qualify if:

• A score of 5 or more on any of the 30 PANSS rating items at screening
• Admission to acute psychiatric unit during 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
• A medical condition with significant cognitive sequelae
• A history of substance dependence during past 6 months
• Currently in pregnancy or breastfeeding

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma for determining concentration of antipsychotics

MeSH Terms

Conditions

Psychotic Disorders; Recurrence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chen-Chung Liu, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Chung Liu, MD, PhD

CONTACT

886-2-23123456; chchliu@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 14, 2017
• Study Start: July 24, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

TW (1)