Efficacy Study on Cognitive Functions in Schizophrenic Patients (AMIMIND)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00761670
First received: September 26, 2008
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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).

Condition Intervention Phase
Schizophrenia
Drug: amisulpride and risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Efficacy of Amisulpride vs Risperidone on Cognitive Functions in Patients With Chronic Schizophrenia

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive measures assessed by individual subscales scores in seven cognitive domains [ Time Frame: Day 0, Day 28, Day 56 ] [ Designated as safety issue: No ]
  • Overall Clinical Effects assessed by the Clinical Global Impression (CGI) [ Time Frame: Day -21 to -1, Day 0, Day 7, Day 28, Day 56 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: September 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: amisulpride and risperidone
amisulpride tablet 400-800 mg/day risperidone tablet 4-8 mg/day
Active Comparator: 2 Drug: amisulpride and risperidone
amisulpride tablet 400-800 mg/day risperidone tablet 4-8 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761670

Locations
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sponsors and Collaborators
Sanofi
Investigators
Study Director: László Erős, MD sanofi-aventis Hungary
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00761670     History of Changes
Other Study ID Numbers: AMISU_L_01008, EudraCT #: 2007-005772-13
Study First Received: September 26, 2008
Last Updated: December 8, 2010
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Sultopride
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 23, 2014