Schizophrenia Clinical Trial
Official title:
Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia
Verified date | May 2012 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.
Status | Terminated |
Enrollment | 28 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patient meets the DSM-IV criteria for schizophrenia - Patient has a PANSS total score = 70 at baseline - Patient has a CGI-S score of = 4(moderately ill) at baseline - Patient is healthy on the basis of physical examination and vital signs at baseline Exclusion Criteria: - Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse - Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen - Patient with unstable or inadequately treated Diabetes Mellitus - Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Research Site | Bangkok | |
Thailand | Research Site | Chiang Mai | |
Thailand | Research Site | Songkla |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Positive and Negative Syndrome Scale (PANSS) Total Score | 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%. |
From Day 1 (baseline) to Day 42 | Yes |
Secondary | Change in Clinical Global Impression - Severity of Illness (CGI-S) Score | 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. | From Day 1 (Baseline) to Day 42 | Yes |
Secondary | Clinical Global Impression - Severity of Illness (CGI-S) Score | 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. | Day 14 | Yes |
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