Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT01357967
Eligibility Criteria:
Inclusion Criteria:
For inclusion in the study patients must fulfill all of the following criteria:
1. Major depressive disorder (HRDS \> 18)
2. N100 amplitude slope outlier (\< 0.21 or \> 1.59)
3. Aged 18 to 55 years
4. Provision of written informed consent prior to any study specific procedures
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
1. Pregnancy or lactation: : urine HCG (-)
2. Any DSM-IV Axis I disorder not defined in the inclusion criteria
3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
4. Known intolerance or lack of response to quetiapine fumarate and SSRI antidepressant, as judged by the investigator
5. Hearing impairment
6. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment 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 3A4 inducers in the 14 days preceding enrollment 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/baseline
9. Substance or alcohol dependence at enrollment (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 enrollment
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 or clinically relevant abnormal laboratory values) as judged by the investigator
13. Involvement in the planning and conduct of the study
14. Previous enrollment or randomisation of treatment in the present study.
15. Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
16. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria
* Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) \> 8.5%
* Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
* Not under physician care for DM
* Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
* Physician responsible for patient's DM care has not approved patient's participation in the study
* Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
* Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
17. An absolute neutrophil count (ANC) of \<= 1.5 x 1,000,000,000 per liter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01357967
Study Brief:
Protocol Section:
NCT01357967