Back to resultsEfficacy Study on Cognitive Functions in Schizophrenic Patients (AMIMIND)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
amisulpride and risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis: DSM-IV schizophrenia (any subtype)
- Duration of illness: ≥ 5 years
- Concomitant standing or prn medications (except other antipsychotics and those contraindicated in the respective package inserts [amisulpride or risperidone]) are permitted during treatment phase, if they were present at a stable dose for at least 6 weeks prior to the start of initial treatment with study medication
- Overall symptom severity: patients must evidence a total score of 60 or higher on the PANSS scale
- Clinical Symptoms: A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom Subscale is present
- Cognitive status (minimum performance level): subject must be able to validly complete the baseline MATRICS assessment
- Clinical judgment by the investigator that treatments with amisulpride or risperidone are warranted due to suboptimal clinical outcome despite previous treatments
Exclusion Criteria:
- Past or current intolerance of amisulpride or risperidone side effects that are judged by the investigator to be unsafe, dose-limiting, or likely to result in study discontinuation.
- Any contraindication for amisulpride or risperidone therapy as indicated in the drug description.
- Presence of any unstable or untreated medical disorder.
- Any history of seizures or seizure disorder other than febrile seizures of childhood;
- History of positive hepatitis B surface antigen.
- Any abnormal laboratory test that is judged to be clinically significant by the investigator.
- A history of significant head injury/trauma, as defined by:
A. loss of consciousness (LOC) for more than 1 hour B. recurring seizures resulting from the head injury C. clear cognitive sequelae of the injury D. cognitive rehabilitation following the injury
- Alcohol or substance dependence within the past 12 months or abuse within the past 3 months. Any subject with positive urine toxicology or alcohol use that is considered abnormal at baseline.
- Clinically significant suicidal or homicidal behavior or attempts within past 6 months.
- Pregnant or breast-feeding women
- Absence of medically approved contraceptive methods for female of childbearing potential.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
General cognitive index, as assessed by the overall average z-score based on the neurocognitive test (MATRICS) battery
Secondary Outcome Measures
Cognitive measures assessed by individual subscales scores in seven cognitive domains
Overall Clinical Effects assessed by the Clinical Global Impression (CGI)
Clinical symptoms Ratings of psychopathology assessed by the PANSS (positive and negative symptoms, general psychopathology), and the SANS (Attention, Affect, Alogia, asociality/Anhedonia;Avolition)
Ratings of potential side affects assessed by the Simpson-Angus Scale (SAS)and the Abnormal Involuntary Movement Scale (AIMS)
General safety/tolerability assessed by vital signs measures, treatment emergent adverse events record, and frequency of abnormal laboratory measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00761670
Brief Title
Efficacy Study on Cognitive Functions in Schizophrenic Patients
Acronym
AMIMIND
Official Title
Comparative Efficacy of Amisulpride vs Risperidone on Cognitive Functions in Patients With Chronic Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary objectives
To compare neurocognitive effects of amisulpride with those of risperidone in patients with chronic schizophrenia, as assessed by the general cognitive index, a measure of overall cognitive functioning in schizophrenia
Secondary objectives
Secondary analyses will be conducted to determine how the two atypical agents' neurocognitive effects compare with regard to their profile of therapeutic action (based on individual cognitive domain scores in seven cognitive domains, including speed of processing, attention/vigilance, working memory, verbal learning and memory, visual learning and memory, reasoning and problem solving and social cognition);
Investigate whether amisulpride elicits more improvement on negative symptoms compared to risperidone treatment, as measured by the total score on the Scale of the Assessment of Negative Symptoms (SANS) 8 and by the Negative Symptom Subscale of the Positive and Negative Symptom Scale (PANSS);
Assess whether amisulpride improves overall functioning and individual domains of psychotic symptoms compared to risperidone as measured by the Clinical Global Impression (CGI), and the total and positive and general psychopathology subscale scores of PANSS and by the individual domains of SANS, respectively;
Evaluate the safety and tolerability of amisulpride and risperidone based on the study completion rates, and frequency of abnormal laboratory values, prolactin serum concentrations and on the Simpson Angus Scale for Extrapyramidal Symptoms (SAS) 10 and the Abnormal Involuntary Movement Scale (AIMS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
amisulpride and risperidone
Intervention Description
amisulpride tablet 400-800 mg/day risperidone tablet 4-8 mg/day
Primary Outcome Measure Information:
Title
General cognitive index, as assessed by the overall average z-score based on the neurocognitive test (MATRICS) battery
Time Frame
Day 0, Day 28, Day 56
Secondary Outcome Measure Information:
Title
Cognitive measures assessed by individual subscales scores in seven cognitive domains
Time Frame
Day 0, Day 28, Day 56
Title
Overall Clinical Effects assessed by the Clinical Global Impression (CGI)
Time Frame
Day -21 to -1, Day 0, Day 7, Day 28, Day 56
Title
Clinical symptoms Ratings of psychopathology assessed by the PANSS (positive and negative symptoms, general psychopathology), and the SANS (Attention, Affect, Alogia, asociality/Anhedonia;Avolition)
Time Frame
Day -21 to -1, Day 0, Day 7, Day 28, Day 56
Title
Ratings of potential side affects assessed by the Simpson-Angus Scale (SAS)and the Abnormal Involuntary Movement Scale (AIMS)
Time Frame
Day 0, Day 7, Day 28, Day 56
Title
General safety/tolerability assessed by vital signs measures, treatment emergent adverse events record, and frequency of abnormal laboratory measures
Time Frame
Day -21 to -1, Day 0, Day 28, Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis: DSM-IV schizophrenia (any subtype)
Duration of illness: ≥ 5 years
Concomitant standing or prn medications (except other antipsychotics and those contraindicated in the respective package inserts [amisulpride or risperidone]) are permitted during treatment phase, if they were present at a stable dose for at least 6 weeks prior to the start of initial treatment with study medication
Overall symptom severity: patients must evidence a total score of 60 or higher on the PANSS scale
Clinical Symptoms: A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom Subscale is present
Cognitive status (minimum performance level): subject must be able to validly complete the baseline MATRICS assessment
Clinical judgment by the investigator that treatments with amisulpride or risperidone are warranted due to suboptimal clinical outcome despite previous treatments
Exclusion Criteria:
Past or current intolerance of amisulpride or risperidone side effects that are judged by the investigator to be unsafe, dose-limiting, or likely to result in study discontinuation.
Any contraindication for amisulpride or risperidone therapy as indicated in the drug description.
Presence of any unstable or untreated medical disorder.
Any history of seizures or seizure disorder other than febrile seizures of childhood;
History of positive hepatitis B surface antigen.
Any abnormal laboratory test that is judged to be clinically significant by the investigator.
A history of significant head injury/trauma, as defined by:
A. loss of consciousness (LOC) for more than 1 hour B. recurring seizures resulting from the head injury C. clear cognitive sequelae of the injury D. cognitive rehabilitation following the injury
Alcohol or substance dependence within the past 12 months or abuse within the past 3 months. Any subject with positive urine toxicology or alcohol use that is considered abnormal at baseline.
Clinically significant suicidal or homicidal behavior or attempts within past 6 months.
Pregnant or breast-feeding women
Absence of medically approved contraceptive methods for female of childbearing potential.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
László Erős, MD
Organizational Affiliation
sanofi-aventis Hungary
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study on Cognitive Functions in Schizophrenic Patients
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