Trial Outcomes & Findings for Seroquel XR in Adults With Schizophrenia (NCT NCT00852631)

NCT ID: NCT00852631

Last Updated: 2012-07-17

Results Overview

Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210. Minimum value considered better is score decreased from baseline at least 30%.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 28 participants
• Primary outcome timeframe: From Day 1 (baseline) to Day 42
• Results posted on: 2012-07-17

Participant Flow

Patients provide informed consent and are screened for eligibility (at Visit 1) up to 7 days before baseline assessment on Day 1.

On Day 1, baseline assessments will be performed, and patients will be assigned to Seroquel XR at 300 mg. On Day 2 all patients are assigned to reach target dose of Seroquel XR at 600 mg. Administration of study medication continue with Seroquel XR 600 mg daily until Day 42. Each visit will have ± 3 days window period.

Participant milestones

Measure	Seroquel XR Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
Overall Study STARTED	28
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Seroquel XR in Adults With Schizophrenia

Baseline characteristics by cohort

Measure	Seroquel XR n=28 Participants Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
Age Continuous	43 Years STANDARD_DEVIATION 39.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 (baseline) to Day 42

Population: The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.

Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210.

Minimum value considered better is score decreased from baseline at least 30%.

Outcome measures

Measure	Seroquel XR n=28 Participants Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
Change in Positive and Negative Syndrome Scale (PANSS) Total Score Day 1 (Baseline) (n= 28)	85.3 Scores on a scale Standard Deviation 28.8
Change in Positive and Negative Syndrome Scale (PANSS) Total Score Day 42 (n= 17)	48.5 Scores on a scale Standard Deviation 28.6

SECONDARY outcome

Timeframe: From Day 1 (Baseline) to Day 42

Population: The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.

Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.

Outcome measures

Measure	Seroquel XR n=28 Participants Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score Day 1 (Baseline) (n= 28)	4.6 Scores on a scale Standard Deviation 0.7
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score Day 42 (n= 17)	2.7 Scores on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Day 14

Population: The number of patient is different, because some of them withdraw/terminate during the study.

Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.

Outcome measures

Measure	Seroquel XR n=21 Participants Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
Clinical Global Impression - Severity of Illness (CGI-S) Score	3.2 Scores on a scale Standard Deviation 1.1

Adverse Events

Seroquel XR

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Seroquel XR n=28 participants at risk Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
Nervous system disorders Seizure	3.6% 1/28

Other adverse events

Measure	Seroquel XR n=28 participants at risk Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
Gastrointestinal disorders Dry Mouth	7.1% 2/28
Gastrointestinal disorders Constipation	10.7% 3/28
Nervous system disorders Dizziness	7.1% 2/28
Nervous system disorders Headache	7.1% 2/28
Vascular disorders Hypotension	10.7% 3/28
Respiratory, thoracic and mediastinal disorders Stiff nose	7.1% 2/28

Additional Information

Gerard Lynch

AstraZeneca

Email: clinicaltrialtransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place