An International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-controlled Study of the Efficacy and Safety of Sustained-release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER Study) - Silver Study

• Conditions: Generalised Anxiety Disorder (GAD)

• Registration Number: EUCTR2005-005054-46-FI
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 805

Inclusion Criteria

1.Provision of informed consent before initiation of any study related procedures.
2.Male or female aged 18 to 65 years, inclusive.
3.A documented clinical diagnosis of generalized anxiety disorder (GAD) according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) criteria 300.02 as assessed by the MINI (Mini-International Neuropsychiatric Interview).
4.HAM-A administered by use of the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) total score =20 with Item 1 (anxious mood) and Item 2 (tension) scores =2 at both enrollment and randomization.
5.A CGI-S score =4 at both enrollment and randomization.
6.Absence of current episode of major depression, documented by a MADRS total score =16 at either enrollment or randomization.
7.Female patients must have a negative serum pregnancy test at enrollment and be willing to use a reliable method of birth control.
8.Be able to understand and comply with the requirements of the study.
9.Be able to read and write and be able to understand and use IVRS.
10.Outpatient status at enrollment and randomization, i.e, patient is not hospitalized.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with a current DSM-IV Axis I disorder other than generalized anxiety disorder or simple phobia within 6 months of enrollment.
2.The presence or history of schizophrenia and other psychotic disorders according to DSM-IV.
3.The presence of any DSM-IV Axis II disorder that is likely to interfere with the patient’s ability to participate in the study as judged by the investigator.
4.Patients who, in the investigator’s judgment, pose a current serious suicidal or homicidal risk or have made a suicide attempt or patients who have a MADRS Item 10 score =4.
5.Evidence of clinically relevant disease, eg, renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS) as judged by the investigator.
6.A clinical finding that is unstable (e.g. hypertension, poorly controlled diabetes, unstable angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.
7.Conditions that could affect absorption and metabolism of study medication (e.g. malabsorption syndrome, liver disease) as judged by the investigator.
8.History of seizure disorder, except febrile convulsions.
9.A current diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years.
10.Current or past diagnosis of stroke or Transient Ischemic Attack (TIA).
11.Pregnancy or lactation.
12.Substance or alcohol abuse or dependence.
13.Use of antipsychotic medication within 28 days prior to randomization.
14.Receipt of electroconvulsive therapy (ECT) within 28 days prior to randomization.
15.Patients who in the investigators opinion will require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomization.
16.Use of benzodiazepines, antidepressants, MAO inhibitors and mood stabilizers within 14 days prior to randomization.
17.Use of benzodiazepines, maximum allowable dose of 10 mg equivalent of diazepam per day, more than 3 times per week in the period 14 to 28 days prior to randomization.
18.Use of hypnotics, maximum allowable single dose of 20 mg zolpidem tartrate, 1 gram chloral hydrate, 20 mg zaleplon, or 7.5 mg zolpiclone, at bedtime more than 3 times per week in the 28 days prior to randomization.
19.Administration of a depot antipsychotic medication within 2 dosing intervals prior to randomization.
20.Use of potent cytochrome P450 3A4 inducers (eg, barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, rifabutin, thioridazine, and St. John’s Wort) in the 14 days preceding randomization.
21.Use of potent cytochrome P450 3A4 inhibitors in the 14 days preceding randomization.
22.A patient with diabetes mellitus.
23.Clinically significant deviation from the reference range in clinical laboratory test results at enrollment, as judged by the investigator.
24.If the patient’s CBC with WBC differential shows an ANC =1.5 x 109/L.
25.A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrollment, whether or not the patient is being treated for hypothyroidism.
26.ECG results considered clinically significant as determined by the investigator based on assessment by a centrally located experienced cardiologist interpreting the ECG.
27.AST, ALT levels > 3 times t

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified