Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic

Completed · Not applicable

Conditions studied: Patient Noncompliance

In brief

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.

Key facts

Study ID

NCT01152697

Run by

University Hospitals Cleveland Medical Center

People needed

30

Starts

2010-06-01

Expected to finish

2012-08-01

Last updated by the study team

2014-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals age 18 years old and older with schizophrenia or schizoaffective disorder as confirmed by the Mini International Psychiatric Inventory (MINI).
• Individuals who are currently or have been recently homeless (within the past 12 months) as per the official federal definition of homelessness.
• 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).
• Ability to be rated on psychiatric rating scales.
• Willingness to take long-acting injectable medication.
• 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.
• Able to provide written, informed consent to study participation.
• Women of child-bearing potential must be utilizing reliable, medically-accepted methods of birth control.

You may not qualify if…

• Known resistance or intolerance to haloperidol or haloperidol decanoate.
• Medical contraindication to haloperidol or haloperidol decanoate.
• Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.
• Prior or current treatment with clozapine.
• 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.
• Current substance dependence.
• High risk of harm to self or others.
• Female who is currently pregnant or breastfeeding.
• Individual who is already in permanent and supported housing that includes comprehensive mental health services (e.g. Housing First).

Where it is running

• University Hosptials — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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