Schizophrenic Disorders
Conditions
Keywords
Schizophrenia, Schizoaffective psychosis, Schizophreniformic psychosis, Pilot study, Quetiapine Prolong, Risperidone
Brief summary
This pilot trial in Finland is designed to evaluate in a randomized fashion change of agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first visits on days 1, 2, 4 or 5 and 7 ± 1.
Interventions
DRUGQuetiapine
Oral administration
DRUGRisperidone
Oral administration
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* In the opinion of the Investigator, requirement for treatment for an acute episode of schizophrenia, schizoaffective disorder or schizophreniformic psychosis (according to DSM-IV diagnostic criteria), Positive and Negative Symptoms Scale (PANSS) ≥ 65, CGI ≥ 4
Exclusion criteria
* Pregnancy or lactation * In-patients/hospitalized \> 7 days before enrollment * Known intolerance or lack of response to quetiapine fumarate or risperidone, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks) | baseline and 3 weeks | PANSS-EC score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS-EC consists of 5 items (Poor IMpulse Control, Tension, Hostility, Uncooperativeness, and Excitement), each with associated descriptors. Each descriptor is rated on a 7 point scale from 1 = (absence of any symptom) to 7 = (extremely severe symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impression, Severity Scale (CGI-S) and in Absolute Clinical Global Impression, Improvement Scale (CGI-I) (Performed 4 Times/ 3 Weeks) | baseline and 3 weeks | The CGI change was to be measured by calculating the difference between baseline score and 3 week's score. CGI-S Score of 1 = no illness to score of 7 = extremely ill. CGI-I Score of 1 =very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment |
| Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks) | baseline and 3 weeks | PANSS score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS consists of 7 positive and 11 negative items each with associated descriptors. Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms). |
| Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks) | baseline and 3 weeks | The Overt Agression Scale (OAS) change was to be measured by calculating the difference between baseline score and 3 week's score. Score between 1 and 16 verbal aggression (OAS 1, score 1-4), physical aggression against objects (OAS 2, score 5-8), physical aggression against self (OAS 3, score 9-11) and physical aggression against other people (OAS 4, score 12-16). |
Countries
Finland
Participant flow
Recruitment details
Two recruiting sites between 13 may 2008 and 28 Jan 2009: Aurora Hospital Helsinki and Pitkäniemi Hospital Tampere.
Pre-assignment details
Site 01 pre-screened 19 subjects, two were randomised, 12 did not consent to participate and five were not included due to other reasons.One subject completed the study and the other discontinued from the study on Day 2 (subject escaped from the hospital).Site 03 pre-screened 10 subjects, of which only one completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Seroquel Quetiapine Prolong, oral administration | 19 |
| Risperdal Risperidone, oral administration | 10 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not consent to participate in study | 12 | 8 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Non Specified reasons | 5 | 0 |
| Overall Study | Participant left hospital | 1 | 0 |
Baseline characteristics
| Characteristic | Seroquel | Risperdal | Total |
|---|---|---|---|
| Age Continuous | 47 years | 51 years | 49 years |
| Gender Female | 1 Participants | 1 Participants | 2 Participants |
| Gender Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks)
PANSS-EC score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS-EC consists of 5 items (Poor IMpulse Control, Tension, Hostility, Uncooperativeness, and Excitement), each with associated descriptors. Each descriptor is rated on a 7 point scale from 1 = (absence of any symptom) to 7 = (extremely severe symptoms).
Time frame: baseline and 3 weeks
Secondary
Change From Baseline in Clinical Global Impression, Severity Scale (CGI-S) and in Absolute Clinical Global Impression, Improvement Scale (CGI-I) (Performed 4 Times/ 3 Weeks)
The CGI change was to be measured by calculating the difference between baseline score and 3 week's score. CGI-S Score of 1 = no illness to score of 7 = extremely ill. CGI-I Score of 1 =very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment
Time frame: baseline and 3 weeks
Secondary
Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)
The Overt Agression Scale (OAS) change was to be measured by calculating the difference between baseline score and 3 week's score. Score between 1 and 16 verbal aggression (OAS 1, score 1-4), physical aggression against objects (OAS 2, score 5-8), physical aggression against self (OAS 3, score 9-11) and physical aggression against other people (OAS 4, score 12-16).
Time frame: baseline and 3 weeks
Secondary
Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)
PANSS score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS consists of 7 positive and 11 negative items each with associated descriptors. Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms).
Time frame: baseline and 3 weeks