SchizophreniaPhase 4AMIMINDNCT00761670
Efficacy Study on Cognitive Functions in Schizophrenic Patients
A Phase 4 study testing amisulpride and risperidone in people with Schizophrenia, run by Sanofi at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- amisulpride and risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2008to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- A history of significant head injury/trauma, as defined by:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Amisulpride vs Risperidone on Cognitive Functions in Patients With Chronic Schizophrenia
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
Read more
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).
- Conditions
- Schizophrenia
- Being tested
- amisulpride and risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amisulpride and risperidoneDrug
amisulpride tablet 400-800 mg/day risperidone tablet 4-8 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: amisulpride and risperidone |
| 2 | Active comparator | Not described Receives: Drug: amisulpride and risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
General cognitive index, as assessed by the overall average z-score based on the neurocognitive test (MATRICS) battery
Measured: Day 0, Day 28, Day 56
Secondary outcomes (5)
Cognitive measures assessed by individual subscales scores in seven cognitive domains
Measured: Day 0, Day 28, Day 56
Overall Clinical Effects assessed by the Clinical Global Impression (CGI)
Measured: Day -21 to -1, Day 0, Day 7, Day 28, Day 56
Clinical symptoms Ratings of psychopathology assessed by the PANSS (positive and negative symptoms, general psychopathology), and the SANS (Attention, Affect, Alogia, asociality/Anhedonia;Avolition)
Measured: Day -21 to -1, Day 0, Day 7, Day 28, Day 56
Ratings of potential side affects assessed by the Simpson-Angus Scale (SAS)and the Abnormal Involuntary Movement Scale (AIMS)
Measured: Day 0, Day 7, Day 28, Day 56
General safety/tolerability assessed by vital signs measures, treatment emergent adverse events record, and frequency of abnormal laboratory measures
Measured: Day -21 to -1, Day 0, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- László Erős, MD, Study director, sanofi-aventis Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761670
- Sponsor's protocol ID
- AMISU_L_01008
- Other IDs
- EudraCT #: 2007-005772-13
- Acronym
- AMIMIND
- Status last verified
- Dec 2010
- First submitted
- 26 Sep 2008
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Amisulpride vs Risperidone on Cognitive Functions in Patients With Chronic Schizophrenia
- ClinicalTrials.gov ID
- NCT00761670
- Acronym / sponsor ID
- AMIMIND / AMISU_L_01008
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: amisulpride and risperidone |
| 2 | Active comparator | Drug: amisulpride and risperidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amisulpride and risperidoneamisulpride tablet 400-800 mg/day risperidone tablet 4-8 mg/day | Drug | 1, 2 |
Primary outcome
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
5 secondary outcomes
Cognitive measures assessed by individual subscales scores in seven cognitive domains
Time frame: Day 0, Day 28, Day 56
Overall Clinical Effects assessed by the Clinical Global Impression (CGI)
Time frame: Day -21 to -1, Day 0, Day 7, Day 28, Day 56
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
László Erős, MD study director
sanofi-aventis Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amisulpride and risperidone in people with Schizophrenia, run by Sanofi at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2010.