A Comparative Study to Evaluate the Evolution of Medication Satisfaction &

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the change of medication satisfaction measured by Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode.

Clinical Trial Description

This is a prospective (patients are first identified and then followed forward as time passes), multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), comparative and open-labeled (all people know the identity of the intervention) study.

The study mainly consists of 3 phases including, the screening phase (14 days before administration of study medication), treatment phase, and the follow-up phase (28 days after the last dose of the study medication). In the treatment phase, patients will be randomly assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown characteristics. Group 1 (immediate switch group): Patients will be administered with paliperidone palmitate immediately after randomization and will continue throughout the treatment phase. Group 2 (delayed switch group): Patients will remain on current oral antipsychotics until Week 8, and later on will be completely switched to paliperidone palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.

Safety evaluations will include evaluation of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination and these will be monitored throughout the study.

The total duration of the study will be approximately 148 days. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Schizophrenia

Clinical Trial Details

NCT number	NCT01682161
Study type	Interventional
Source	Janssen Korea, Ltd., Korea
Contact
Status	Completed
Phase	Phase 4
Start date	January 2012
Completion date	September 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05039489` - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia	N/A
Completed	`NCT05321602` - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder	Phase 1
Completed	`NCT05111548` - Brain Stimulation and Cognitive Training - Efficacy	N/A
Completed	`NCT04503954` - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia	N/A
Completed	`NCT02831231` - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium	Phase 1
Completed	`NCT05517460` - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center	N/A
Completed	`NCT03652974` - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy	Phase 4
Recruiting	`NCT04012684` - rTMS on Mismatch Negativity of Schizophrenia	N/A
Recruiting	`NCT04481217` - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia	N/A
Completed	`NCT00212784` - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)	Phase 3
Completed	`NCT04092686` - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia	Phase 3
Completed	`NCT01914393` - Pediatric Open-Label Extension Study	Phase 3
Recruiting	`NCT03790345` - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics	Phase 2/Phase 3
Recruiting	`NCT05956327` - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training	N/A
Terminated	`NCT03209778` - Involuntary Memories Investigation in Schizophrenia	N/A
Terminated	`NCT03261817` - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders	N/A
Completed	`NCT02905604` - Magnetic Stimulation of the Brain in Schizophrenia or Depression	N/A
Recruiting	`NCT05542212` - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia	N/A
Completed	`NCT04411979` - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia	N/A
Terminated	`NCT03220438` - TMS Enhancement of Visual Plasticity in Schizophrenia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Comparative Study to Evaluate the Evolution of Medication Satisfaction and Adherence in Patients Unsatisfied With Current Oral Atypical Antipsychotics by Switching Medication to Paliperidone Palmitate

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms