A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients - Full Text View

Sponsor:	Indiana University
Collaborator:	AstraZeneca
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00619892

Purpose

The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus placebo.

Condition	Intervention	Phase
Panic Disorder	Drug: quetiapine SR Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	An 8-week, Randomized, Double-Blind, Placebo-Controlled Trial of Seroquel SR Co-administration for SSRI-Resistant, Comorbid Panic Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Panic Disorder

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

Decrease in mean total Panic Disorder Symptom Scale (PDSS) scores [ Time Frame: First 1 to 3 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Decrease in scores in measurements of depressive (Hamilton Depression Rating Scale), generalized anxiety symptoms (Hamilton Anxiety Rating Scale) and sleep quality (Pittsburgh Sleep Quality Index). [ Time Frame: End of 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: quetiapine SR Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
2: Placebo Comparator	Drug: placebo Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of written informed consent
Diagnosis of Panic Disorder by DSM-IV TR and confirmed by MINI plus interview
Females and males ages 18-65 years old
Female patients of childbearing potential must by using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
Able to understand and comply with the requirements of the study
Have a CGI illness severity score = or > 4
Patients with comorbid major depression, dysthymia or other anxiety problems are eligible to participate as well.

Exclusion criteria:

Pregnancy or lactation
Any DSM-IV TR Axis I disorder not mentioned in the inclusion requirements
Suicidal or danger to self or others
Known intolerance to quetiapine fumarate or intolerance to SSRI therapy
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
Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to : phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV TR criteria within 4 weeks prior to enrollment
Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension) as judged by the investigator
Involvement in the planning and conduct of the study
Previous enrollment or randomization of treatment in the present study
Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
A patient with a diagnosis of Type I or Type II Diabetes Mellitus (DM)
An absolute neutrophil count (ANC) of 1.5 x 109 per liter
A lifetime history of a pre-existing CNS/neurological disorder e.g. epilepsy, TBI, brain tumor
Patient with severe personality disorders
Patients who have started a new course of psychotherapy (CBT, supportive, insight-oriented) within 1 month of the screening visit
Patients unwilling to refrain from participation in psychotherapy during the 9-week period of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619892

Contacts

Contact: Carla E Medlock, BA, CCRP

(317) 274-0314

cemedloc@iupui.edu

Locations

United States, Indiana
University Hospital Outpatient Center, Psychiatry	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Carla E Medlock, B.A. 317-274-0314 cemedloc@iupui.edu

Sponsors and Collaborators

Indiana University

AstraZeneca

Investigators

Principal Investigator:

Andrew W. Goddard, M.D.

Indiana University

More Information

No publications provided

Responsible Party:	Indiana University School of Medicine, Department of Psychiatry ( Andrew W. Goddard / Professor of Psychiatry )
Study ID Numbers:	0703-22, 4587082, IRUSQUET0445
Study First Received:	February 11, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00619892 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

SSRI Resistant
Seroquel SR
Seroquel XR
Panic Disorder

Comorbid Panic Disorder
Quetiapine SR
Quetiapine XR

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions

Panic Disorder
Quetiapine
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2010