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The specific aim of this study is to determine whether the new, long-acting, form of risperidone, Risperdal Consta, improves the ability of schizophrenia patients to benefit from skills training. The hypothesis guiding this study is that Risperdal Consta, by improving verbal memory, will improve the ability to benefit from skills training interventions among schizophrenia patients. The primary objective of this study is to compare patients on Risperdal Consta to patients on other atypical antipsychotic medications in terms of their ability to benefit from skills training interventions. A secondary objective of this study is to determine whether patients taking Risperdal Consta improve in other areas of cognitive functioning and social functioning.
Full description
The study will be conducted at the University of Illinois at Chicago and New York Presbyterian Hospital-Westchester Division. Patients with schizophrenia or schizoaffective disorder who are considered by their clinicians to not be clinically stable, or to be stable but still symptomatic, will be referred to the study. After obtaining informed consent, patients will be randomized either to the Risperdal Consta or control conditions. Patients in the control condition will remain on their oral antipsychotic medication for the duration of the study (note - patients currently taking oral risperidone will not be eligible for the study). Patients randomized to the Consta condition will take oral risperidone for 3 days, and if there are no adverse effects, they will begin receiving injections of Consta every 2 weeks over the next 6 months. During the first month, they will remain on oral risperidone, which will be tapered by the end of the month along with other antipsychotic medications other than Consta. At baseline, and every 4 weeks for 6 months, all patients will complete a computerized cognitive testing battery (CogTest), and be interviewed about social functioning and symptomatology. During months 4-6 of study participation, all patients will participate in a social skills group, the UCLA Basic Conversation Skills Module. Before and after this group, patients will be interviewed and participate in role-play based assessments regarding skills to be taught in the group. Patients will also receive physical exams, including and ECG, at baseline, and be monitored for side effects and adverse events every 2 weeks. The hypothesis driving this study is that patients in the Consta group will demonstrate greater improvement in verbal learning, skill acquisition in the training group, and improved social functioning, over the course of the 6 months. This hypothesis is based on prior data demonstrating that oral risperidone improves verbal memory, which is a mediator of skill acquisition in structured skills training groups. If this hypothesis is supported, it would be an important demonstration that a novel medication preparation (injectable Risperdal Consta) can, when combined with psychiatric rehabilitation, improve functional outcomes for patients participating in rehabilitation.
Efficacy Measures:
Adverse Events: Side effects and adverse events will be assessed using a semi-structured interview given by a research nurse or psychiatrist. There are 40 specific side effects in 6 categories (general, neurological, cardiovascular, autonomic, urologic, muscular skeletal). Adverse events will be rated on an intensity scale of 0 to 4 and a relationship to medication of 0 to 5. Side effects will be counted as adverse events for scores of 3 or 4 on intensity (moderate or severe) and scores of 3-5 for relationship (possible to definite). These adverse events will then be aggregated into one of the 6 groups for analysis across groups.
Serious adverse events will include those that require medical intervention such as additional monitoring by the subject's primary physician or medical hospitalization. All significant adverse events (such as those listed above or any side effect with an intensity level of 4) will be reviewed with the treating psychiatrist and the independent medical reviewers. Each site will have two independent medical reviewers (one internist, one psychiatrist) to examine any serious or significant adverse events and determine if the subject should be withdrawn from the study. The two reviewers will not be directly connected to the research group and will not be investigators in the protocol.
In addition to the assessment of side effects, other scales will be used to measure side effects commonly associated with antipsychotic medications. Each month, a blinded research assistant will perform an Abnormal Involuntary Movement Scale (AIMS, to assess for tardive dyskinesia), Barnes Akathisia Scale, and Simpson-Angus Scale (to assess for dystonia and parkinsonian side effects). Movement disorders can affect the ability of patients to perform on cognitive tests and in skills training groups. Patients with akathisia often have reduced attention and reduced ability to concentrate in groups. Patients with parkinsonian symptoms can be slower on manual tasks and may have slower mental abilities.
Laboratory Assessment (to be done at baseline and last month of participation):
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Data sourced from clinicaltrials.gov
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