Schizophrenia Clinical Trial
Official title:
A Concierge Model of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAL-C) in Individuals With Schizophrenia at Risk for Treatment Non-adherence and for Homelessness
This is a prospective study using a concierge model of customized adherence enhancement and long-acting injectable antipsychotic (CAL-Concierge) in 30 individuals with schizophrenia or schizoaffective disorder at risk for treatment non-adherence and for homelessness. Like the CAE-L approach, CAL-Concierge is expected to improve health outcomes among the most vulnerable of populations with schizophrenia but even more importantly, will demonstrate that it can be used to improve the efficiency and quality of care in typical practice settings.
Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia,
but rates of full or partial non-adherence exceed 60%. There is direct correlation between
non-adherence and rates of relapse in schizophrenia; on average, non-adherent patients have a
risk of relapse that is 3.7 times greater than their adherent counterparts. Long-acting
injectable antipsychotic (LAI) medication can improve adherence but needs to be combined with
a quality behavioral program to modify long-term attitudes and behaviors.
A recently completed study funded by the Reuter Foundation and conducted by these
investigators found that a novel customized psychosocial adherence enhancement intervention
paired with LAI (CAE-L) reduced rates of homelessness, improved psychiatric symptoms and
increased overall functioning in this very vulnerable group of individuals. CAE has been
manualized and appears very acceptable to homeless people with serious mental illness.
However, in spite of the very promising results, the CAE-L intervention has some important
limitations that are barriers to its wide-spread future use in public health settings. These
limitations are:
1. CAE-L used a PhD-level psychologist to deliver the behavioral part of the program. Many
public-sector clinical settings have a very limited number of such highly trained
individuals. As an alternative, social workers could be an efficient way to deliver CAE.
2. CAE-L used only haloperidol decanoate as the injectable medication. Unfortunately,
akathisia-- a very distressing side effect, occurred in 40% of people. Use of a newer,
better tolerated medication option could improve the investigators approach.
3. Logistic barriers preventing people who were stabilized and doing well on CAE-L to
continue their improved functioning once they transitioned back to regular care
settings. It is clear that there needs to be a mechanism to facilitate the successful
"hand-off" of individuals who have benefitted from CAE-L into maintenance therapy. A
successful transition could have substantial financial and humanitarian cost-savings.
To address these obstacles and in preparation for a large-scale randomized controlled trial
of this novel, blended intervention the investigators propose to conduct a prospective study
using a concierge model of customized adherence enhancement combined with a long-acting
injectable antipsychotic (CAL-Concierge) in individuals with schizophrenia at risk for
treatment non-adherence and for homelessness. Like the CAE-L approach, CAL-Concierge is
expected to improve health outcomes among the most vulnerable of populations with
schizophrenia but even more importantly, will demonstrate that it can be used to improve the
efficiency and quality of care in typical practice settings.
;
| 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 |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
| Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
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 |