Depression
Conditions
Interventions
Trade Name: Seroquel 25 mg
Product Name: Seroquel
Pharmaceutical Form: Tablet
INN or Proposed INN: Quetiapine
CAS Number: 248919-64-4
Sponsors
AstraZeneca UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent. 2. Male or female aged 18 years and over. 3. Current DSM-IV Major Depressive Episode with a minimum MADRS score of 20. 4. Treatment resistant depression, defined as failure to respond to 2 adequate treatment trials. An adequate treatment trial will be defined as, at least, 6 weeks of an antidepressant at an accepted effective dose (150 mg or greater for tricyclic antidepressant, British National Formulary (BNF) doses for other antidepressants), 6 weeks lithium augmentation or 8 sessions of ECT within a 6 week period. 5. Currently taking a monoamine reuptake inhibitor (SSRI, noradrenaline reuptake inhibitor or SNRI). 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females. Females of childbearing potential must use a reliable method of contraception, i.e. hormonal contraceptives, double-barrier methods, intra-uterine device and tubal ligation unless their sexual partner is sterile (vasectomy). 2. Alcohol or substance abuse. 3. A primary DSM-IV axis 1 diagnosis of schizophrenia or other non-affective psychosis. 4. Previous failure to respond, or adverse reaction, to quetiapine. Current treatment with quetiapine. 5. Inability to understand English to a degree that would invalidate assessments or compromise consent. 6. Previous inclusion in the present study, concurrent inclusion in another clinical study with an investigational drug or participation in a previous clinical study within 90 days of enrolment (Visit 1). 7. Concurrent treatment with any antipsychotic medication (not including mood stabilisers). Previous antipsychotic medication must have been stopped at least 14 days prior to study enrolment. (Previous antipsychotic medication is defined as those drugs listed in the BNF under Central Nervous System: Drugs used in psychoses and related disorders). 8. Concomitant use of fluvoxamine or nefazadone (CYP P450 3A4 inhibitors). 9. Use of any of the following potent cytochrome P450 inhibitors / inducers in the 14 days preceding enrolment (Visit 1) or during the study: Inhibitors: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir and saquinavir. Inducers: phenytoin, carbamazepine, barbiturates, rifampin, St John’s Wort and glucocorticoids. 10. Evidence of any other clinically relevant disease e.g. gastrointestinal, renal, hepatic, haematological, endocrine, or other clinical finding, as judged by the Investigator, to interfere with the conduct of the study or the safety of the subject. 11. Subjects who, in the Investigator’s judgment, pose a current serious suicidal or homicidal risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of quetiapine in the treatment of depression at 8 weeks, assessed by calculation of the proportion of subjects responding by week 8, derived from the change in Montgomery Asberg Depression Rating Scale (MADRS) score from baseline to week 8.; Secondary Objective: 1. To assess the change in MADRS score. 2. To assess the proportion of subjects achieving remission, defined as MADRS score less than or equal to 12. 3. To obtain preliminary data on the speed of onset of antidepressant action with assessments at weeks 1 and 2. 4. To determine the effect of quetiapine on anxiety associated with depression. 5. To assess if predefined variables predict response to quetiapine (anxiety, insomnia, depression and treatment resistance). 6. To assess safety and tolerability by measuring frequency and severity of adverse events, random plasma glucose, serum prolactin, routine haematology and biochemistry, vital signs and weight. ;Primary end point(s): The primary outcome variable of the study is the percentage of subjects responding to treatment, that is subjects experiencing > 50% decrease in MADRS score by week 8. | — |
Countries
United Kingdom
Outcome results
None listed