Status:
COMPLETED
A Double Blind, Randomized Placebo Controlled Study of the Efficacy, Safety and of Quetiapine Fumarate (Seroquel®) as Potentiation SSRI's, and SNRI's Treatment in Major Depression With Anxiety
Lead Sponsor:
Dr Alexander McIntyre Inc.
Conditions:
Major Depression With Comorbid Anxiety Symptoms
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Major depression occurs with generalized anxiety disorder and panic disorder in up to 60% of psychiatric and primary care patients.(1) An estimated 85% of adults with depression experience significant...
Detailed Description
This is a double blind study where patients will be involved and be under treatment for a period of 8 weeks. The initial evaluation will include rating scales measuring depression, anxiety, severity o...
Eligibility Criteria
Inclusion
- 1\. Patients with a DSM IV diagnosis of major depression. 2. Patients will not be on an antipsychotic or a benzodiazepine for at least 7 days prior to entering the study.
- 3\. Patients will be able to give informed consent. 4. Patients will be male or female between the ages of 18 and 65. 5. Subjects have been treated for at least 6 weeks of single agent SSRI or SNRI therapy at an acceptable dose (see table 1 for detail) in the current episode.
- 6\. Patients who score at least 18 on the 17-item HAM-D scale, a score of at least 14 on the 14-item HAM-A scale and at least 4 (i.e., moderately ill) on the Clinical Global Impression (CGI) severity scale. Both criteria have to be met at screening and baseline (Study Day 0).
Exclusion
- 1\. Patients who, in the investigator's opinion, pose a risk for suicide. 2. Present DSM IV diagnosis of substance abuse or dependence within 6 months of the screening visit.
- 3\. Female subjects of child bearing potential without adequate contraception. Adequate methods of contraception include hormonal contraceptives e.g. oral contraceptives or long term injectable or implantable hormonal contraceptive; double barrier methods, for example condom and diaphragm, condom and foam, condom and sponge; intrauterine device and tubal ligation.
- 4\. Pregnant or breastfeeding females. 5. Documented disease of the central nervous system including but not limited to stroke, tumor, seizure disorder requiring anticonvulsants, history of brain trauma, chronic infection or a dementing illness.
- 6\. Hepatic, renal or gastrointestinal disease of sufficient degree to interfere with the excretion, absorption and/or metabolism of trial medication.
- 7\. Acute, unstable or significant and untreated medical illness. 8. Subjects with narrow angle glaucoma, chronic urinary retention and/or clinically significant prostatic hypertrophy, paralytic ileus or related conditions.
- 9\. A history of severe drug allergy or hypersensitivity. 10. The use of any of the following potent cytochrome P450 inhibitors in the 14 days preceding randomization (e.g. ketoconazole, itraconazole, fluconazole, erythromycin, troleandomycin clarithromycin, indinavir, nelfinavir, ritonavir and saquinavir).
- 11\. The use of potent cytochrome P450 inducers (e.g. phenytoin, carbamazepine, barbiturates, rifampin and glucocorticoids) in the 14 days preceding randomization.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00229645
Start Date
November 1 2003
End Date
April 1 2005
Last Update
July 13 2016
Active Locations (1)
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1
Dr. A. McIntyre
Penticton, British Columbia, Canada, V2A 3G6