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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00660595
• Collaborator: (none)
• Enrollment: 29
• Locations: 4
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 7.3
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenic Disorders	Drug: Quetiapine; Drug: Risperidone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Three-Week, Randomised, Open Comparison in Schizophrenic In-patients Treated With Quetiapine Prolong or Oral Risperidone at Flexible Dose
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Oral	Drug: Quetiapine; Oral administration; Other Names: Seroquel
Active Comparator: 2 Oral	Drug: Risperidone; Oral administration; Other Names: Risperdal

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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).

3. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Harjavalta		Finland
2	Research Site	Helsinki		Finland
3	Research Site	Pitkaniemi		Finland
4	Research Site	Turku		Finland

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Yrjö Ovaskainen, MD, AstraZeneca Finland
• Principal Investigator: Hannu Koponen, MD, PhD, Kuopio University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00660595
• Other Study ID Numbers: D1443L00042
• First Posted: Apr 17, 2008
• Last Update Posted: Sep 17, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: Schizophrenia; Schizoaffective psychosis; Schizophreniformic psychosis; Pilot study; Quetiapine Prolong; Risperidone
• Additional relevant MeSH terms: Schizophrenia; Risperidone; Quetiapine Fumarate

Study Results

Participant Flow

Recruitment Details	Two recruiting sites between 13 may 2008 and 28 Jan 2009: Aurora Hospital Helsinki and Pitkäniemi Hospital Tampere.
Pre-assignment Detail	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.

Arm/Group Title	Seroquel	Risperdal
Arm/Group Description	Quetiapine Prolong, oral administration	Risperidone, oral administration
Period Title: Overall Study
STARTED	19	10
COMPLETED	1	1
NOT COMPLETED	18	9

Baseline Characteristics

Arm/Group Title	Seroquel	Risperdal	Total
Arm/Group Description	Quetiapine Prolong, oral administration	Risperidone, oral administration	Total of all reporting groups
Overall Participants	19	10	29
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	47	51	49
Gender (Number) [Number]
Female	1 5.3%	1 10%	2 6.9%
Male	0 0%	1 10%	1 3.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seroquel	Risperdal
Arm/Group Description	Quetiapine Prolong, oral administration	Risperidone, oral administration
Measure Participants	0	0

2. Secondary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seroquel	Risperdal
Arm/Group Description	Quetiapine Prolong, oral administration	Risperidone, oral administration
Measure Participants	0	0

3. Secondary Outcome

Title	Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seroquel	Risperdal
Arm/Group Description	Quetiapine Prolong, oral administration	Risperidone, oral administration
Measure Participants	0	0

4. Secondary Outcome

Title	Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Seroquel	Risperdal
Arm/Group Description	Quetiapine Prolong, oral administration	Risperidone, oral administration
Measure Participants	0	0

Adverse Events

Arm/Group Title	Seroquel		Risperdal
Arm/Group Description	Quetiapine Prolong, oral administration		Risperidone, oral administration
All Cause Mortality
	Seroquel		Risperdal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Seroquel		Risperdal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Seroquel		Risperdal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		1/1 (100%)
Endocrine disorders
Elevated Prolactin Level	0/1 (0%)		1/1 (100%)
Musculoskeletal and connective tissue disorders
Muscle spasms	0/1 (0%)		1/1 (100%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.