Quetiapine Augmentation In Treatment-Resistant Depression – An Open Pilot Study
- Conditions
- Depression
- Registration Number
- EUCTR2005-003251-13-GB
- Lead Sponsor
- AstraZeneca UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
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
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.
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