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

NCT00229645 | Completed Phase 4

• 1 other identifier: D1441C00017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Major Depression With Comorbid Anxiety Symptoms

Keywords

Major Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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

• 1. Hamilton Depression Scale (HAM-D) total score,

• 2. Hamilton Anxiety Scale (HAM-A) total score

Interventions

Quetiapine Fumarate (Seroquel®) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. 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).

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. Hepatic, renal or gastrointestinal disease of sufficient degree to interfere with the excretion, absorption and/or metabolism of trial medication.
• \. 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.
• \. 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).
• \. The use of potent cytochrome P450 inducers (e.g. phenytoin, carbamazepine, barbiturates, rifampin and glucocorticoids) in the 14 days preceding randomization.

Sponsors & Collaborators

• Dr Alexander McIntyre Inc.: lead

Study Sites (1)

Dr. A. McIntyre

Penticton, British Columbia, V2A 3G6, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alexander W McIntyre, FRCPC

  Dr Alexander McIntyre Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 30, 2005
• Study Start: November 1, 2003
• Study Completion: April 1, 2005
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

CA (1)