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Trial record 4 of 5 for:    OAS2

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

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ClinicalTrials.gov Identifier: NCT00660595
Recruitment Status : Terminated (To difficult to recruit patients in the acute setting)
First Posted : April 17, 2008
Results First Posted : September 17, 2010
Last Update Posted : September 17, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenic Disorders
Interventions Drug: Quetiapine
Drug: Risperidone
Enrollment 29
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.
Arm/Group Title Seroquel Risperdal
Hide Arm/Group Description Quetiapine Prolong, oral administration Risperidone, oral administration
Period Title: Overall Study
Started 19 10
Completed 1 1 [1]
Not Completed 18 9
Reason Not Completed
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
Arm/Group Title Seroquel Risperdal Total
Hide Arm/Group Description Quetiapine Prolong, oral administration Risperidone, oral administration Total of all reporting groups
Overall Number of Baseline Participants 19 10 29
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants 10 participants 29 participants
47
(47 to 47)
51
(39 to 63)
49
(47 to 63)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 10 participants 29 participants
Female 1 1 2
Male 0 1 1
[1]
Measure Description: randomised participants
1.Primary Outcome
Title Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel Risperdal
Hide Arm/Group Description:
Quetiapine Prolong, oral administration
Risperidone, oral administration
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel Risperdal
Hide Arm/Group Description:
Quetiapine Prolong, oral administration
Risperidone, oral administration
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel Risperdal
Hide Arm/Group Description:
Quetiapine Prolong, oral administration
Risperidone, oral administration
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel Risperdal
Hide Arm/Group Description:
Quetiapine Prolong, oral administration
Risperidone, oral administration
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Seroquel Risperdal
Hide Arm/Group Description Quetiapine Prolong, oral administration Risperidone, oral administration
All-Cause Mortality
Seroquel Risperdal
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Seroquel Risperdal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Seroquel Risperdal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   1/1 (100.00%) 
Endocrine disorders     
Elevated Prolactin Level  1  0/1 (0.00%)  1/1 (100.00%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  0/1 (0.00%)  1/1 (100.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD.10
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: Hans Eriksson - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00660595     History of Changes
Other Study ID Numbers: D1443L00042
First Submitted: April 14, 2008
First Posted: April 17, 2008
Results First Submitted: December 4, 2009
Results First Posted: September 17, 2010
Last Update Posted: September 17, 2010