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) in Combination with an Antidepressant in the Treatment of Patients with Major Depressive Disorder with Inadequate Response to an Antidepressant Treatment (ONYX STUDY) - ONYX STUDY

• Conditions: Major Depressive Disorder (MDD).

• Registration Number: EUCTR2005-005053-22-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1.Provision of written informed consent before initiation of any study related procedures.
2.Male and female patients aged 18 to 65 years, inclusive.
3.Documented clinical diagnosis meeting criteria from the DSM-IV for any of the following;296.2x Major Depressive Disorder, Single Episode, or 296.3x Major Depressive Disorder, Recurrent as confirmed by the MINI.
4.HAM-D total score of =20 and HAM-D item 1 score =2 both at enrolment (Visit 1) and randomisation (Visit 2).
5.Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control (i.e. barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during the study.
6.Have a history during the current depressive episode of an in-adequate response to one of the following antidepressants: amitryptyline, bupropion, citalopram, duloxetine, escitralopram, fluoxetine, paroxetine, sertraline or venlafaxine. An inadequate response is defined as having at least minimum effective antidepressant dose according to label for 6 weeks including at least one dose increase when permitted according to label at enrolment.
7.Be able to understand and comply with the requirements of the study, as judged by the investigator.
8.Outpatient status at enrolment.
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 DSM-IV Axis I disorder other than MDD within 6 months of enrolment.
2.Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status.
3.Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment.
4.Substance or alcohol abuse or dependence within 6 months prior to enrolment.
5.Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4 enzymes within 2 weeks prior to randomisation.
6.Pregnancy or lactation.
7.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).
8.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.
9.Conditions that could affect absorption and metabolism of study medication.
10.A current diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years.
11.Current or past diagnosis of stroke or Transient Ischemic Attacks (TIA).
12.History of seizure disorder, except febrile convulsions.
13.Receipt of electroconvulsive therapy (ECT) within 90 days prior to randomisation.
14.Use of mood stabiliser other than allowed, or other antipsychotic or psychoactive drugs within 7 days before randomisation, or use of MAO inhibitors, anxiolytic drugs or hypnotics (except medications specified in Table 5) within 14 days before randomisation, or use of a depot antipsychotic injection within two dosing interval before randomisation.
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 randomisation.
16.Patients who, in the investigator’s judgement pose a current serious suicidal or homicidal risk, have a HAM-D item 3 score of 3 or greater, or have made a suicide attempt within the past 6 months.
17.A patient with diabetes mellitus.
18.Clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator.
19.An absolute neutrophil count (ANC) of =1.5 x 109 per litre.
20.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 enrolment, whether or not the patient is being treated for hypothyroidism.
21.Liver function tests (AST or ALT) three times the upper normal limit.
22.ECG results considered being clinically significant as determined by the investigator based on assessment by a centrally located experienced cardiologist interpreting the ECG.
23.Use of quetiapine in doses >25 mg/day for insomnia within 7 days before randomisation.
24.Known history of intolerance or hypersensitivity to quetiapine or to any other component in the tablets.
25.Known lack of response to quetiapine in the treatment of depression in a dosage of at least 50 mg/day for 4 weeks (at any time before study start), as judged by the investigator.
26.Treatment with quetiapine with a dosage of =50 mg/day at enrolment (visit 1).
27.Contraindications as detailed in the country-specific prescribing information for quetiapine.
28.Involvement in the planning and conduct of the study (applies to all AstraZeneca, investig

Study & Design

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