A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono-Therapy in the Treatment of Elderly Patients with Major Depressive Disorder (SAPPHIRE STUDY) - SAPPHIRE STUDY
- Conditions
- Major Depressive Disorder (MDD)
- Registration Number
- EUCTR2006-001196-38-FI
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 375
1.Provision of written informed consent before initiation of any study related procedures.
2.Male and female patients aged 66 years or older.
3.Documented clinical diagnosis meeting criteria from the DSM-IV as assessed by M.I.N.I. for any of the following; 296.2x Major Depressive Disorder, Single Episode, or
296.3x Major Depressive Disorder, Recurrent.
4.HAM D total score of =22 and HAM D item 1 score =2 both at enrolment (Visit 1) and randomisation (Visit 2).
5.Be able to understand and comply with the requirements of the study, as judged by the investigator.
6.Outpatient status and living in home environment at enrolment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
1.A Mini Mental State Examination (MMSE) score =25.
2.Patients meeting the DSM-IV Diagnostic Criteria for Dementia of the Alzheimer’s type; DSM-IV 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 MDD within 6 months of enrolment.
4.Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status.
5.Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment.
6.History of in-adequate response to an adequate dose (6 weeks) with 2 or more classes of antidepressants during current or previous depressive episode(s).
7.Patients treated with antihypertensive medications must be on a stable dose for at least 30 days prior to enrolment.
8.Substance or alcohol abuse or dependence.
9.Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4 enzymes within 2 weeks prior to randomisation.
10.Evidence of clinically relevant disease.
11.A clinical finding that is unstable.
12.Conditions that could affect absorption and metabolism of study medication (e.g., malabsorption syndrome, liver disease).
13.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.
14.A current diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years.
15.Current or past diagnosis of stroke.
16.History of seizure disorder, except febrile convulsions.
17.Prior history of Neuroleptic Malignant Syndrome.
18.Receipt of electroconvulsive therapy (ECT) within 90 days prior to randomisation.
19.Use of antipsychotic, mood stabilizer, or antidepressant drugs within 7 days before randomisation, or use of fluoxetine within 28 days before randomisation, or use of MAO inhibitors, anxiolytic 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 two dosing intervals before randomisation.
20.Patients unable to swallow oral medications whole or have difficulty swallowing.
21.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 and will continue until study completion.
22.Patients who, in the investigator’s judgement pose a current serious suicidal or homicidal risk or have a HAM D item 3 score of 3 or greater.
23.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 lesion, etc.
24.A patient with diabetes mellitus fulfilling certain criteria.
25.Clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator.
26.An absolute neutrophil count (ANC) of =1.5 x 109 per litre.
27.A thyroid-stimulating hormone (TSH) concentration more than 10% abo
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method