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Bipolar DisorderPhase 3NCT00671853

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

A Phase 3 study testing Quetiapine XR in people with Bipolar Disorder and Anxiety, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder, Anxiety, Anxiety Disorders
What is being tested?
Quetiapine XR
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
Apr 2008to Mar 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Quetiapine XR, Placebo for quetiapine XR
Keywords
Bipolar Disorder, Anxiety, Anxiety Disorders, Substance Use Disorders
Medical subject headings
Bipolar Disorder, Anxiety Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quetiapine XRDrug

    Also called Seroquel XR

    Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day

  • Placebo for quetiapine XRDrug

    Also called Placebo for Seroquel XR

    Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day

Study groups in NCT00671853
Study groupRoleWhat they receive
1ExperimentalQuetiapine XR
Receives: Drug: Quetiapine XR
2Placebo comparatorPlacebo for quetiapine XR
Receives: Drug: Placebo for quetiapine XR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score

    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.

    Measured: Week 0 - Week 8

Secondary outcomes (5)

  1. Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)

    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.

    Measured: Week 0 - Week 8

  2. Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)

    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.

    Measured: Week 0 - Week 8

  3. Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score

    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.

    Measured: Week 0 - Week 8

  4. Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score

    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.

    Measured: Week 0 - Week 8

  5. Change in Hamilton Rating Scale for Anxiety (HAM-A)

    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

    Measured: Week 0 - Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00671853
Sponsor's protocol ID
10-06-19
Status last verified
Nov 2016
First submitted
1 May 2008
Last updated
29 Dec 2016
Data monitoring committee
Yes

Publications

  • Gao K, Wu R, Kemp DE, Chen J, Karberg E, Conroy C, Chan P, Ren M, Serrano MB, Ganocy SJ, Calabrese JR. Efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar depression with generalized anxiety disorder and other comorbidities: a randomized, placebo-controlled trial. J Clin Psychiatry. 2014 Oct;75(10):1062-8. doi: 10.4088/JCP.13m08847.

    PubMed 25007003

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quetiapine XR in people with Bipolar Disorder and Anxiety, run by University Hospitals Cleveland Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score (time frame: Week 0 - Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00671853, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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