Quetiapine Extended Release (XR) in Bipolar Patients With Comorbid Generalized Anxiety Disorder (GAD)

November 9, 2016 updated by: Keming Gao, University Hospitals Cleveland Medical Center

Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder

The primary objective is to test the hypothesis that Quetiapine XR (Extended Release) monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. The secondary aim is to generate an estimate of effect size to power a definitive large-scale, multi-site collaborative R01 and to configure the use of the primary and secondary outcome measures in the definitive large-scale study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

120 subjects aged 18 and up with Diagnostic and Statistical Manual -IV Generalized Anxiety Disorder and Bipolar Disorder type I or II as identified by extensive clinical interview and the Mini-International Neuropsychiatric Interview (MINI) will be enrolled and randomized. Assignment to each arm will be balanced for BP I vs BP II; male vs female; and with vs without SUD. Potential participants will be recruited by means of Institutional Review Board -approved advertising or from the clinical psychiatric infrastructure.

This study is a randomized, double-blind, placebo-controlled, 8-week comparison of quetiapine sustained-release monotherapy or adjunctive mood stabilizer therapy vs. placebo in the acute treatment of comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. Subjects will be assessed weekly for mood changes and side effects.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic and Statistical Manual-IV diagnosis of bipolar I or II disorder, and currently depressed as confirmed by the MINI-Plus at Screening.
  • Diagnostic and Statistical Manual-IV diagnosis of lifetime GAD;
  • Hamilton Depression Rating Scale -17 items total score ≥ 18;
  • Hamilton Anxiety Rating Scale total score ≥ 18;
  • Be male or female at least 18 year old and not older than 65.

Exclusion Criteria:

  • Pregnancy or breast feeding.
  • Severe medical or neurological problems.
  • Severe personality disorder.
  • Currently suicidal risk judged by physician.
  • Known history of intolerance or hypersensitivity to any of the medications involved in the study.
  • Treatment with quetiapine at any dose in the 6 months prior to randomization.
  • Known lack of response to quetiapine in a dosage of at least 50 mg for 4 weeks at any time, as judged by the investigator.
  • Dependence on opiate, phencyclidine (PCP), and/or barbiturate.
  • Acute mania as determined by a score > 12 on the Young Mania Rating Scale at baseline.
  • Concurrent obsessive compulsive disorder.
  • Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment 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 randomisation
  • Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  • Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
  • Involvement in the planning and conduct of the study
  • Previous enrolment or randomisation of treatment in the present study.
  • Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
  • A patient with diabetes mellitus (DM) fulfilling one of the following criteria: a. Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) .8.5% b. Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks c. Not under physician care for DM d. Physician responsible for patient's DM care has not indicated that the patient's DM is controlled f. Physician responsible for patient's DM care has not approved the patient's participation in the study g. Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks before randomization h. Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Quetiapine XR
Drug: Quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Other Names:
  • Seroquel XR
PLACEBO_COMPARATOR: 2
Placebo for quetiapine XR
Drug: Placebo for quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
Other Names:
  • Placebo for Seroquel XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score
Time Frame: Week 0 - Week 8
A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
Week 0 - Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)
Time Frame: Week 0 - Week 8
A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.
Week 0 - Week 8
Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)
Time Frame: Week 0 - Week 8
A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. Remission is defined by the number of participants with Hamilton Rating Scale for Depression score equal to or less than 7.
Week 0 - Week 8
Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score
Time Frame: Week 0 - Week 8

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.

1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Week 0 - Week 8
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score
Time Frame: Week 0 - Week 8
This assessment degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with a higher score indicating less enjoyment and satisfaction.
Week 0 - Week 8
Change in Hamilton Rating Scale for Anxiety (HAM-A)
Time Frame: Week 0 - Week 8
The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe
Week 0 - Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

National Alliance for Research on Schizophrenia and Depression
AstraZeneca

Investigators

  • Principal Investigator: Keming Gao, PhD, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (ESTIMATE)

May 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-06-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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