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

Study identifier:D1443L00042

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

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

Medical condition

Schizophrenic Disorders

Phase

Phase 3

Healthy volunteers

Study drug

Quetiapine, Risperidone

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Sept 2008

Primary Completion Date: 01 Dec 2008

Study Completion Date: 01 Dec 2008

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2010 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Harjavalta, Finland

Location

Research Site

Helsinki, Finland

Location

Research Site

Pitkaniemi, Finland

Location

Research Site

Turku, Finland

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

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Two recruiting sites between 13 may 2008 and 28 Jan 2009: Aurora Hospital Helsinki and Pitkäniemi Hospital Tampere.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Seroquel	Quetiapine Prolong, oral administration
Risperdal	Risperidone, oral administration

Participant Flow: Overall Study

	Seroquel	Risperdal
STARTED	19	10
COMPLETED	1	1^[1]
NOT COMPLETED	18	9
Lost to Follow-up	0	1
Did not consent to participate in study	12	8
Participant left hospital	1	0
Non Specified reasons	5	0

[1]	One of the two was lost to follow-up

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Seroquel	Quetiapine Prolong, oral administration
Risperdal	Risperidone, oral administration

Baseline Measures

	Seroquel	Risperdal	Total
Number of Participants [units: Participants]	19	10	29
Age Continuous [units: years] Mean ( Full Range )	47 (47 to 47)	51 (39 to 63)	49 (47 to 63)
Gender, Male/Female ^[1] [units: Participants]
Female	1	1	2
Male	0	1	1

Outcome Measures

1. Primary Outcome Measure: Change from baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) score (Time Frame: 3 weeks) [ Time Frame: baseline and 3 weeks ]

Measure Type	Primary
Measure Name	Change from baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) score (Time Frame: 3 weeks)
Measure 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
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Seroquel	Quetiapine Prolong, oral administration
Risperdal	Risperidone, oral administration

Measured Values

	Seroquel	Risperdal
Number of Participants Analyzed [units:participants]	0	0
Change from baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) score (Time Frame: 3 weeks) [units: units on a scale]

No statistical analysis provided for Change from baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) score (Time Frame: 3 weeks)

2. Secondary Outcome Measure: 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) [ Time Frame: baseline and 3 weeks ]

Measure Type	Secondary
Measure Name	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)
Measure 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
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Seroquel	Quetiapine Prolong, oral administration
Risperdal	Risperidone, oral administration

Measured Values

	Seroquel	Risperdal
Number of Participants Analyzed [units:participants]	0	0
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) [units: units on a scale]

No statistical analysis provided for 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)

3. Secondary Outcome Measure: Change from baseline in Overt Aggression Scale (OAS) (performed 6 times/ 3 weeks) [ Time Frame: baseline and 3 weeks ]

Measure Type	Secondary
Measure Name	Change from baseline in Overt Aggression Scale (OAS) (performed 6 times/ 3 weeks)
Measure 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
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Seroquel	Quetiapine Prolong, oral administration
Risperdal	Risperidone, oral administration

Measured Values

	Seroquel	Risperdal
Number of Participants Analyzed [units:participants]	0	0
Change from baseline in Overt Aggression Scale (OAS) (performed 6 times/ 3 weeks) [units: units on a scale]

No statistical analysis provided for Change from baseline in Overt Aggression Scale (OAS) (performed 6 times/ 3 weeks)

4. Secondary Outcome Measure: Change from baseline in total Positive and Negative Symptoms Scale (PANSS score) (performed 5 times/ 3 weeks) [ Time Frame: baseline and 3 weeks ]

Measure Type	Secondary
Measure Name	Change from baseline in total Positive and Negative Symptoms Scale (PANSS score) (performed 5 times/ 3 weeks)
Measure 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
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Seroquel	Quetiapine Prolong, oral administration
Risperdal	Risperidone, oral administration

Measured Values

	Seroquel	Risperdal
Number of Participants Analyzed [units:participants]	0	0
Change from baseline in total Positive and Negative Symptoms Scale (PANSS score) (performed 5 times/ 3 weeks) [units: units on a scale]

No statistical analysis provided for Change from baseline in total Positive and Negative Symptoms Scale (PANSS score) (performed 5 times/ 3 weeks)

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Seroquel	Quetiapine Prolong, oral administration
Risperdal	Risperidone, oral administration

Serious Adverse Events

	Seroquel	Risperdal
Total, serious adverse events
# participants affected / at risk	0/1 (0.00%)	0/1 (0.00%)

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Seroquel	Quetiapine Prolong, oral administration
Risperdal	Risperidone, oral administration

Other Adverse Events

Seroquel

Risperdal

Total, other (not including serious) adverse events

# participants affected / at risk

0/1 (0.00%)

1/1 (100.00%)

Musculoskeletal and connective tissue disorders

Muscle spasms¹,^†

# participants affected / at risk

0/1 (0.00%)

1/1 (100.00%)

Endocrine disorders

Elevated Prolactin Level¹,^†

# participants affected / at risk

0/1 (0.00%)

1/1 (100.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, ICD.10
2	Term from vocabulary,

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=264&filename=CSR-D1443L00042.pdf
Download
CSR-D1443L00042.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Finland Clinical Study Information

+358 10 23 010

yrjo.ovaskainen@astrazeneca.com

Investigators

Principal Investigator

Yrjö Ovaskainen

AstraZeneca Finland

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

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

CSR-D1443L00042.pdf

Trial Results Summaries