search
Back to results

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

Primary Purpose

Panic Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
quetiapine XR
placebo
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring SSRI Resistant, Seroquel SR, Seroquel XR, Panic Disorder, Comorbid Panic Disorder, Quetiapine SR, Quetiapine XR

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Outpatient Center, Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Quetiapine XR

Placebo

Arm Description

Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy & the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, & 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).

Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 11, 2008
Last Updated
December 15, 2015
Sponsor
Indiana University
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00619892
Brief Title
A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients
Official Title
An 8-week, Randomized, Double-Blind, Placebo-Controlled Trial of Seroquel SR Co-administration for SSRI-Resistant, Comorbid Panic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
SSRI Resistant, Seroquel SR, Seroquel XR, Panic Disorder, Comorbid Panic Disorder, Quetiapine SR, Quetiapine XR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine XR
Arm Type
Active Comparator
Arm Description
Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy & the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, & 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).
Intervention Type
Drug
Intervention Name(s)
quetiapine XR
Other Intervention Name(s)
Seroquel SR, Seroquel XR
Intervention Description
Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Astra Zeneca placebo
Intervention Description
Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
Primary Outcome Measure Information:
Title
Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores
Description
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 Outcome Measure Information:
Title
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).
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew W. Goddard, M.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Outpatient Center, Psychiatry
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26379759
Citation
Goddard AW, Mahmud W, Medlock C, Shin YW, Shekhar A. A controlled trial of quetiapine XR coadministration treatment of SSRI-resistant panic disorder. Ann Gen Psychiatry. 2015 Sep 15;14:26. doi: 10.1186/s12991-015-0064-0. eCollection 2015.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs