Trial Outcomes & Findings for Study in Schizophrenic In-patients Treated With Quetiapine Prolong or Oral Risperidone at Flexible Dose (NCT NCT00660595)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

29 participants

Primary outcome timeframe

baseline and 3 weeks

Results posted on

2010-09-17

Participant Flow

Two recruiting sites between 13 may 2008 and 28 Jan 2009: Aurora Hospital Helsinki and Pitkäniemi Hospital Tampere.

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.

Participant milestones

Participant milestones
Measure	Seroquel Quetiapine Prolong, oral administration	Risperdal Risperidone, oral administration
Overall Study STARTED	19	10
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	18	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Seroquel Quetiapine Prolong, oral administration	Risperdal Risperidone, oral administration
Overall Study Lost to Follow-up	0	1
Overall Study Did not consent to participate in study	12	8
Overall Study Participant left hospital	1	0
Overall Study Non Specified reasons	5	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Seroquel n=19 Participants Quetiapine Prolong, oral administration	Risperdal n=10 Participants Risperidone, oral administration	Total n=29 Participants Total of all reporting groups
Age Continuous	47 years n=5 Participants	51 years n=7 Participants	49 years n=5 Participants
Gender Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

Adverse Events

Seroquel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Risperdal

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Seroquel n=1 participants at risk Quetiapine Prolong, oral administration	Risperdal n=1 participants at risk Risperidone, oral administration
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1	100.0% 1/1
Endocrine disorders Elevated Prolactin Level	0.00% 0/1	100.0% 1/1

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60