Clinical trial NCT01152697: Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic
Official title: A Prospective Trial of Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic (CAE-L) in Individuals With Schizophrenia or Schizoaffective Disorder at Risk for Treatment Non-adherence and for Homelessness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Noncompliance
Keywords: nonadherence
noncompliance
homeless
schizophrenia
schizoaffective
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2010-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Psychotropic medications are a cornerstone of treatment for individuals with schizophrenia and schizoaffective disorder, however rates of full or partial non-adherence can exceed 60%. Inadequate adherence is associated with poor outcomes such as relapse, homelessness, hospitalization, and increased health care costs. Studies have shown a 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. A major obstacle to good outcomes in the maintenance treatment of patients with severe mental illness is difficulty with medication routines on an on-going basis. For this reason, long-acting injectable antipsychotic medication is a particularly attractive treatment option for populations with schizophrenia and schizoaffective disorder, although it is unlikely that medication treatment alone is likely to modify long-term attitudes and behaviors.

This prospective study is a pilot analysis of a combined approach which merges a psychosocial intervention to optimize treatment attitudes towards psychotropic medication (CAE) and long-acting injectable antipsychotic medication (L) in recently homeless individuals with schizophrenia or schizoaffective disorder who are known to have on-going difficulties with treatment non-adherence. It is expected that this combined approach (CAE-L) will improve illness outcomes among the most vulnerable of populations with schizophrenia or schizoaffective disorder.


Eligibility criteria: Inclusion Criteria:

1. Individuals age 18 years old and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI).
2. Individuals who are currently or have been recently homeless (within the past 12 months) as per the official federal definition of homelessness.
3. Known to have medication treatment adherence (20% or more missed medications in past week or past month) problems as identified by the Treatment Routines Questionnaire patient or clinician versions (TRQ-P/TRQ-C).
4. Ability to be rated on psychiatric rating scales.
5. Willingness to take long-acting injectable medication.
6. Currently receiving treatment at a Community Mental Health Clinic (CMHC) or another mental health treatment provider who is able to provide continuity of care during and after study participation.
7. Able to provide written, informed consent to study participation.
8. Women of child-bearing potential must be utilizing reliable, medically-accepted methods of birth control.

Exclusion Criteria:

1. Known resistance or intolerance to haloperidol or haloperidol decanoate.
2. Medical contraindication to haloperidol or haloperidol decanoate.
3. Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.
4. Prior or current treatment with clozapine.
5. Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial.
6. Current substance dependence.
7. High risk of harm to self or others.
8. Female who is currently pregnant or breastfeeding.
9. Individual who is already in permanent and supported housing that includes comprehensive mental health services (e.g. Housing First).

Primary outcomes:
measure: Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks
timeFrame: Baseline-25 weeks
measure: Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks
timeFrame: Baseline-25 weeks
measure: Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks
timeFrame: Baseline-25 weeks
measure: Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks
timeFrame: Baseline-25 weeks
measure: Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks
timeFrame: Baseline-25 weeks
Secondary outcomes:
measure: Frequency of Health Resource Use Throughout Months 10, 11, and 12
timeFrame: Month 1-3, Month 10-12
measure: Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks
timeFrame: Baseline-25 weeks
measure: Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks
timeFrame: Baseline-25 weeks
measure: Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks
timeFrame: Baseline-25 weeks
measure: Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks
timeFrame: 25 weeks
measure: Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks
timeFrame: Baseline-25 weeks
measure: Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks
timeFrame: 25 weeks
measure: Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months
timeFrame: 12 months
measure: Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months
timeFrame: Baseline-12 months
measure: Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months
timeFrame: 12 months
measure: Days Homeless Out of the Previous 6 Months as Measured at 12 Months
timeFrame: 12 months
measure: Treatment Adherence Score as Measured at 12 Months
timeFrame: 12 months
measure: Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months
timeFrame: 12 months
measure: Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months
timeFrame: 12 months
measure: Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hosptials
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sajatovic M, Levin J, Ramirez LF, Hahn DY, Tatsuoka C, Bialko CS, Cassidy KA, Fuentes-Casiano E, Williams TD. Prospective trial of customized adherence enhancement plus long-acting injectable antipsychotic medication in homeless or recently homeless individuals with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2013 Dec;74(12):1249-55. doi: 10.4088/JCP.12m08331.