Generalised Anxiety Disorder
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of written informed consent before initiation of any study related procedures 2.Men and women aged 66 years or older 3.A documented clinical diagnosis of GAD according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria 300.02 as assessed by M.I.N.I. 4.A HAM-A total score =20 with Item 1 (anxious mood) and Item 2 (tension) scores =2 at both enrolment and randomisation 5.A CGI-S score =4 at both enrolment and randomisation 6.Absence of current episode of major depression, defined as having a MADRS total score of =16 at both enrolment and randomisation 7.Be able to understand and comply with the requirements of the study, as judged by the investigator 8.Outpatient status and living in home environment at enrolment and randomisation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.A Mini Mental State Examination (MMSE) score =25 2.Patients meeting the DSM-IV Diagnostic Criteria for Dementia of the Alzheimer’s type; Diagnostic Criteria for Vascular Dementia; DSM-IV Diagnostic Criteria for Dementia Due to Other General Medical Conditions (e.g., head trauma, intracranial structural abnormality, etc); Practice Parameter for Mild Cognitive Impairment (Neurology 2001;56: 1133-1142); Diagnostic Criteria of The Consortium for Dementia with Lewy Bodies; and the Consensus Diagnostic Criteria for Frontotemporal Dementia 3.Patients with a DSM-IV Axis I disorder other than GAD or simple phobia within 6 months of enrolment, which is considered clinically relevant as judged by the investigator. 4.Patients with a DSM-IV Axis II disorder having a major impact on the current psychiatric status. 5.Patients who, in the investigator’s judgement, pose a current serious suicidal or homicidal risk or have made a suicide attempt within 6 months prior to randomization or patients who have a MADRS Item 10 score =4. 6.Patients treated with antihypertensive medications must be on a stable dose for at least 30 days prior to Visit 1. 7.Substance or alcohol abuse or dependence,. 8.Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4 enzymes within 2 weeks prior to randomisation. 9.Evidence of clinically relevant disease, e.g., renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS) as judged by the investigator. 10.A clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication. 11.Conditions that could affect absorption and metabolism of study medication (e.g., malabsorption syndrome, liver disease) as judged by the investigator. 12.Significant hearing dysfunction, visual impairment, or communication disabilities that would interfere with the accurate assessment of the patient or impact the conduct of the study. 13.A current diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years. 14.Current or past diagnosis of stroke. 15.History of seizure disorder, except febrile convulsions. 16.Prior history of Neuroleptic Malignant Syndrome. 17.Receipt of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) fo treatment of depression within 90 days prior to randomisation, or the presence of a vagal nerve sti,ulator (VNS) device. 18.Use of antipsychotic, mood stabiliser, or antidepressant drugs within 7 days before randomisation, or use of fluoxetine within 28 days before randomisation, or use of monamine oxidase inhibitors (MAO inhibitors), anxiolytics or hypnotics within 14 days before randomisation (with the exception of those allowed with restriction per protocol), or use of a depot antipsychotic injection within 2 dosing interval before randomisation. 19.Patients unable to swallow oral medications whole or have difficulty swallowing. 20.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 randomisation. 21.Patients with any diagnosis of a neurological condition, such as Parkinson’s disease, Huntington’s disease, essential tremor, multiple sclerosis, prior brain injury, space-occupying lesi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of quetiapine fumarate sustained release (hereafter referred to as quetiapine SR) versus placebo in the treatment of anxiety symptoms in patients with Generalised Anxiety Disorder (GAD), as assessed by the change from randomisation in the HAM A total score at Day 64.;Secondary Objective: 1.The efficacy of quetiapine SR versus placebo by evaluating the response rate in the treatment of anxiety symptoms in patients with GAD. 2.The efficacy of quetiapine SR versus placebo on the health-related quality of life of patients with GAD. 3.The efficacy of quetiapine SR versus placebo in the treatment of anxiety symptoms in patients with GAD. 4.The efficacy of quetiapine SR versus placebo by evaluating the remission rate in the treatment of anxiety symptoms in patients with GAD. 5.The efficacy of quetiapine SR versus placebo in the treatment of depressive symptom in patients with GAD. 6.The efficacy of quetiapine SR versus placebo in improving somatic symptoms in the treatment of patients with GAD. 7.The efficacy of quetiapine SR versus placebo in improving sleep quality in patients with GAD. 8.If quetiapine SR improves satisfaction with medication in patients with GAD, compared with placebo. 9.The safety and tolerability of quetiapine SR in patients with GAD. ;Primary end point(s): The primary objective of the study is to evaluate the efficacy of quetiapine fumarate sustained release (hereafter referred to as quetiapine SR) versus placebo in the treatment of anxiety symptoms in patients with Generalised Anxiety Disorder (GAD), as assessed by the change from randomisation in the HAM A total score at Day 64. | — |
Countries
Estonia
Outcome results
None listed