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

NCT00619892 | Completed Phase 4 Results DMC

• 2 other identifiers: 0703-22IRUSQUET0445
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder

Keywords

SSRI Resistant; Seroquel SR; Seroquel XR; Panic Disorder; Comorbid Panic Disorder; Quetiapine SR; Quetiapine XR

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and the end of 8 weeks of treatment

Secondary Outcomes (1)

• 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).

  Comparing baseline and the end of 8 weeks of treatment

Study Arms (2)

Quetiapine XR

ACTIVE COMPARATOR

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).

Drug: quetiapine XR

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

quetiapine XR DRUG

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

Also known as: Seroquel SR, Seroquel XR

Quetiapine XR

placebo DRUG

Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.

Also known as: Astra Zeneca placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or lactation
• 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

Sponsors & Collaborators

• Indiana University: lead
• AstraZeneca: collaborator

Study Sites (1)

University Hospital Outpatient Center, Psychiatry

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 26379759 DERIVED

MeSH Terms

Conditions

Panic Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Andrew Goddard, M.D.
• Organization: UCSF Fresno

agoddard@fresno.ucsf.edu

559-499-6580

Study Officials

• Andrew W. Goddard, M.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 21, 2016
• Results First Posted: January 21, 2016

Record last verified: 2015-12

Locations

US (1)