Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148083
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2005-09-02
Brief Title:
Effects of Risperdal Consta on Ability to Benefit From Social Skills Training in Schizophrenia
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Efficacy of Risperidone Consta for Improving Ability to Benefit From Skills Training in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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
1 The primary efficacy measure for this study will be the Micro-Module Learning Tests MMLT Silverstein et al in press This is a set of 7 psychometrically equivalent tests that assess responsiveness to the key components of skills training Each test has 3 parts 1 a verbal learning component wherein the patient is read material from an actual skills training group and then asked questions about the material 2 a modeling component in which the patient views a model performing a specific behavior on a videotape and is then asked questions about what was viewed and 3 a role-play component in which the patient is asked to demonstrate via a role-play the behavior that the model demonstrated in the prior section The MMLT is a dynamic assessment measure in that in addition to measuring what people can recallperform after an initial presentation of information it allows for a determination of learning potential after repeated exposure to the information With the MMLT each time a question is initially answered incorrectly a briefer version of the material that highlights the most relevant information is presented If an incorrect answer is given at this point an even more focused version of the item is presented With this scoring system responsiveness to skills training as it occurs in the real world where repetition of material is built into the teaching method can be assessed more accurately than when using a static assessment where information is only presented once
2 A second primary efficacy measure will be the Comprehensive Module Test for the Basic Conversation Skills Module This measure is administered before and after the group
3 A secondary efficacy measure is the CogTest computerized cognitive battery This battery was developed by Tonmoy Sharma MD and colleagues and has been used with over 2000 schizophrenia patients in studies of risperidone or Consta to date
4 Another secondary efficacy measure is the Social Functioning Scale SFS Birchwood et al 1990 This is a 74 item scale that is rated by the patient The SFS has seven subscales 1 social engagementwithdrawal 2 interpersonal communication 3 independence-performance of activities of daily living 4 independence-competence to perform activities of daily living 5 frequency of engagement in recreational activities 6 frequency of participation in social activities and 7 employment
5 A third secondary efficacy measure will be the observational measure of attentiveness in groups that was developed as part of the PIs current NIMH grant on cognitive rehabilitation in schizophrenia This measure will allow us to determine 1 if Risperdal Consta is improving a real-world measure of attention and 2 whether there are any relationships between skill acquisition medication and attention
6 The final efficacy measure will be the Positive and Negative Syndrome Scale which will be used to measure symptoms
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 subjects 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
1 Complete Blood Count CBC to determine major hematological indices as some antipsychotic medications affect the white count
2 Complete Chemistries including electrolytes BUN creatinine liver function tests and glucose Some antipsychotic medications may increase the risk of diabetes and some medications may cause an increase in liver enzymes
3 Lipid profile including cholesterol triglycerides LDL and HDL Some antipsychotic medications cause an increase in lipids particularly triglycerides
4 Prolactin some antipsychotics may increase prolactin leading to menstrual irregularities sexual dysfunction and possibly osteoporosis Months 0 3 6 only
5 Thyroid stimulating hormone TSH thyroid functioning can affect cognition Patients with a history of hypothyroidism will be allowed in the study if they are on stable dose of replacement and the TSH is in the normal range Months 0 3 6 only
6 Glycohemoglobin HgA1c to measure the overall level of glucose over the prior 2-3 months Months 0 3 6 only
Laboratory Assessment monthly
1 For women of childbearing potential urine screen for pregnancy
Efficacy Measures
1 The primary efficacy measure for this study will be the Micro-Module Learning Tests MMLT Silverstein et al in press This is a set of 7 psychometrically equivalent tests that assess responsiveness to the key components of skills training Each test has 3 parts 1 a verbal learning component wherein the patient is read material from an actual skills training group and then asked questions about the material 2 a modeling component in which the patient views a model performing a specific behavior on a videotape and is then asked questions about what was viewed and 3 a role-play component in which the patient is asked to demonstrate via a role-play the behavior that the model demonstrated in the prior section The MMLT is a dynamic assessment measure in that in addition to measuring what people can recallperform after an initial presentation of information it allows for a determination of learning potential after repeated exposure to the information With the MMLT each time a question is initially answered incorrectly a briefer version of the material that highlights the most relevant information is presented If an incorrect answer is given at this point an even more focused version of the item is presented With this scoring system responsiveness to skills training as it occurs in the real world where repetition of material is built into the teaching method can be assessed more accurately than when using a static assessment where information is only presented once
2 A second primary efficacy measure will be the Comprehensive Module Test for the Basic Conversation Skills Module This measure is administered before and after the group
3 A secondary efficacy measure is the CogTest computerized cognitive battery This battery was developed by Tonmoy Sharma MD and colleagues and has been used with over 2000 schizophrenia patients in studies of risperidone or Consta to date
4 Another secondary efficacy measure is the Social Functioning Scale SFS Birchwood et al 1990 This is a 74 item scale that is rated by the patient The SFS has seven subscales 1 social engagementwithdrawal 2 interpersonal communication 3 independence-performance of activities of daily living 4 independence-competence to perform activities of daily living 5 frequency of engagement in recreational activities 6 frequency of participation in social activities and 7 employment
5 A third secondary efficacy measure will be the observational measure of attentiveness in groups that was developed as part of the PIs current NIMH grant on cognitive rehabilitation in schizophrenia This measure will allow us to determine 1 if Risperdal Consta is improving a real-world measure of attention and 2 whether there are any relationships between skill acquisition medication and attention
6 The final efficacy measure will be the Positive and Negative Syndrome Scale which will be used to measure symptoms
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 subjects 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
1 Complete Blood Count CBC to determine major hematological indices as some antipsychotic medications affect the white count
2 Complete Chemistries including electrolytes BUN creatinine liver function tests and glucose Some antipsychotic medications may increase the risk of diabetes and some medications may cause an increase in liver enzymes
3 Lipid profile including cholesterol triglycerides LDL and HDL Some antipsychotic medications cause an increase in lipids particularly triglycerides
4 Prolactin some antipsychotics may increase prolactin leading to menstrual irregularities sexual dysfunction and possibly osteoporosis Months 0 3 6 only
5 Thyroid stimulating hormone TSH thyroid functioning can affect cognition Patients with a history of hypothyroidism will be allowed in the study if they are on stable dose of replacement and the TSH is in the normal range Months 0 3 6 only
6 Glycohemoglobin HgA1c to measure the overall level of glucose over the prior 2-3 months Months 0 3 6 only
Laboratory Assessment monthly
1 For women of childbearing potential urine screen for pregnancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-04081 UIC | None | None | None |