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

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Panic Disorder

Intervention: quetiapine SR (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Indiana University

Official(s) and/or principal investigator(s):
Andrew W. Goddard, M.D., Principal Investigator, Affiliation: Indiana University

Summary

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.

Clinical Details

Official title: An 8-week, Randomized, Double-Blind, Placebo-Controlled Trial of Seroquel SR Co-administration for SSRI-Resistant, Comorbid Panic Disorder

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

Primary outcome: Decrease in mean total Panic Disorder Symptom Scale (PDSS) scores

Secondary outcome: 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).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

University Hospital Outpatient Center, Psychiatry, Indianapolis, Indiana 46202, United States
Additional Information

Starting date: February 2008
Last updated: March 26, 2013

Page last updated: August 23, 2015

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