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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Study in Schizophrenic In-patients Treated with Quetiapine Prolong or Oral Risperidone at Flexible Dose

Research Site

A Pilot Study of Three-Week, Randomised, Open Comparison in Schizophrenic In-patients Treated with Quetiapine Prolong or Oral Risperidone at Flexible Dose

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).

Age Continuous

Gender, Male/Female

Change from baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) score  (Time Frame: 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 Clinical Global Impression, severity scale (CGI-S) and in absolute Clinical Global Impression, improvement scale (CGI-I) (performed 4 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).

Change from baseline in Overt Aggression Scale (OAS) (performed  6 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).

Change from baseline in total Positive and Negative Symptoms Scale (PANSS score) (performed 5 times/ 3 weeks)

Overall Study

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.

Arms	Assigned Interventions
Experimental: 1 Oral	Drug: Quetiapine Oral administration Other Name: Seroquel
Active Comparator: 2 Oral	Drug: Risperidone Oral administration Other Name: Risperdal

Study in Schizophrenic In-patients Treated with Quetiapine Prolong or Oral Risperidone at Flexible Dose

Official Title

Medical condition

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Healthy volunteers

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Study design

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=264&filename=CSR-D1443L00042.pdf

CSR-D1443L00042.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator