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

Phase 4CompletedNCT00619892

Indiana University26 enrolled

Overview

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.

This was a single-site, double-blind, placebo-controlled (PLAC), randomized, parallel group (2 groups), 8-week, quetiapine extended release (XR) coadministration trial. SSRI resistance was determined either historically or prospectively. Patients were randomized if they remained moderately ill (CGI-S score ≥ 4). Change in the PDSS scale total score was the primary efficacy outcome measure. Responders were identified as those with a ≥50 % decrease from their baseline PDSS score. In the early weeks of therapy, XR was flexibly and gradually titrated from 50 to 400 mg/day. Conclusions: This proof-of-concept RCT did not support the efficacy of this treatment strategy for SSRI-resistant PD. Quetiapine XR was generally well-tolerated. Important limitations were the small sample size, and the relatively low average dose of quetiapine XR used.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Panic Disorder

Interventions

quetiapine XRDRUG

Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.

placeboDRUG

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

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (1)

University Hospital Outpatient Center, Psychiatry

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores

Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.

Time frame: Baseline and the end of 8 weeks of treatment

Secondary Outcomes

Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).

Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM-A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.

Time frame: Comparing baseline and the end of 8 weeks of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.