Major Depression With Comorbid Anxiety Symptoms Clinical Trial
Official title:
A Double Blind, Randomized Placebo Controlled Study of the Efficacy, Safety and Tolerability of Immediate-Release Formulation of Quetiapine Fumarate as Potentiation of Selective Serotonin Reuptake Inhibitors, and Serotonin Norepinephrine Reuptake Inhibitors Treatment in Major Depression With Comorbid Anxiety Symptoms
| Verified date | July 2016 |
| Source | Dr Alexander McIntyre Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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 symptoms of anxiety and 58% have a diagnosable anxiety disorder
during their lifetime.(2) Numerous studies have shown that symptoms of anxiety are frequent
in patients with major depressive disorder, and the presence of anxiety symptoms is
associated with a more severe and chronic course.(3,4) This comorbidity has been associated
with a greater severity of depression, poorer psychosocial functioning, poorer treatment
response and higher risk for suicide.
The data suggests that novel antipsychotics have antidepressant and anxiolytic effects. This
study will explore the impact of this effect in patients with major depression and comorbid
anxiety symptoms.
This study offers the possibility of systematically reviewing the role of quetiapine in
depression with anxiety. If the combination of an SSRI or SNRI and quetiapine proves to
effective it could offer a viable alternative to widespread benzodiazepine use.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | April 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Dr. A. McIntyre | Penticton | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Dr Alexander McIntyre Inc. |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To compare the efficacy of quetiapine versus placebo over 8 weeks as an adjunctive agent for unipolar non-psychotic adult outpatients on SSRI or SNRI therapy with residual symptoms of depression and comorbid anxiety symptoms. This will be measured by the | |||
| Primary | 1. Hamilton Depression Scale (HAM-D) total score, | |||
| Primary | 2. Hamilton Anxiety Scale (HAM-A) total score |