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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00619892
First received: February 11, 2008
Last updated: March 26, 2013
Last verified: March 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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 ]

Enrollment: 26
Study Start Date: February 2008
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: quetiapine SR
Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
Other Names:
  • Seroquel SR
  • Seroquel XR
Placebo Comparator: 2 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

Locations
United States, Indiana
University Hospital Outpatient Center, Psychiatry
Indianapolis, Indiana, United States, 46202
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
ClinicalTrials.gov Identifier: NCT00619892     History of Changes
Other Study ID Numbers: 0703-22, 4587082, IRUSQUET0445
Study First Received: February 11, 2008
Last Updated: March 26, 2013
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:
Panic Disorder
Anxiety Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 16, 2014