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This study examines how genetic variation in the serotonin transporter relates to the brain's (amygdala) response to the medication Quetiapine XR in people with major depression. Adults aged 18-65 with a diagnosis of major depressive disorder were able to take part. The study was carried out in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria 1. A diagnosis of Major Depressive Disorder of unipolar subtype by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) and a score of 18 on the 17-item Hamilton Rating Scale for Depression (HRSD) (Hamilton 1960). 2. Both females and males aged 18 to 65 years of Caucasian descent.The association between 5-HTTLPR- s allele and poor response to SSRIs is significant only in Caucasians 3. Female patients of childbearing potential must be using a acceptable method of contraception ( contraceptive pill, injection or patch, vaginal ring, intra-uterine device, female condom, contraceptive sponge, diaphragm, cervical cap, lea contraceptive, tubal ligation, natural birth control methods, and withdrawl) and have a negative urine human chorionic gonadotropin (HCG) test at enrolment. 4. Able to understand and comply with the requirements of the study 5 All participants should be free of psychotropic medication for a minimum of 4 weeks at recruitment Exclusion Criteria: 1. Pregnancy or lactation 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria. 3. Major depression with mood congruent and incongruent psychotic symptoms 4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 5. Known intolerance or lack of response to quetiapine fumarate and citalopram as judged by the investigator 6. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir 7. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids 8. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation 9. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria 10. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment will be excluded. However, patient with occasional use of above mentioned substance but does not fulfil abuse criteria according to DSM-IV during the defined period will be included in the study. 11. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 12. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator 13. Involvement in the planning and conduct of the study 14. Previous enrolment or randomisation of treatment in the present study. 15. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements 16. A patient with unstable Diabetes Mellitus (DM) 17 Subjects who are contraindicated for MRI (pregnancy, metal implants) will be excluded. 18\. Severe claustrophobia