Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms

NCT00277667 | Completed Phase 3

• 1 other identifier: IRUSQUET0302
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate the safety, tolerability, and efficacy of quetiapine compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Quetiapine is approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania.

Conditions

Bipolar Disorder

Keywords

currently experiencing hypomania or mild mania

Outcome Measures

Primary Outcomes (1)

• Change in manic symptoms (as measured by Young Mania Rating Scale)

  baseline to endpoint

Secondary Outcomes (1)

• Change in total burden of affective symptoms, depressive symptoms alone, and anxiety symptoms alone; change in clinical global improvement; adherence with study medication; and degree and severity of side effects experienced.

  baseline to endpoint

Interventions

Quetiapine DRUG

Oral dosing: 50mg (Day 1), 100mg (Day 2), 150mg (Day 3), 200mg (Day 4), followed by flexible dosing from 50mg to 800mg through day 56.

Eligibility Criteria

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

You may qualify if:

• Subjects must be 18 years of age or older.
• Subjects must have bipolar I, II, or not otherwise specified (NOS) disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. Of note, bipolar NOS disorder will include subjects with either recurrent or sporadic brief hypomanias (hypomanias of 1 to 3 days in duration).
• Subjects must have moderate-to-severe hypomanic symptoms or mild manic symptoms that must be clinically significant (at least mild) but no worse than moderately severe, defined as a CGI-BP scale for mania \> 3 and \< 5, on at least 2 assessment days at least 3 days apart during the screening phase.
• Subjects must not be receiving mood stabilizing, antidepressant, or antipsychotic medication for \> one week.
• Subjects or their legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained.
• If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable, effective method(s) of contraception (e.g., hormonal methods, intrauterine device) for at least one month prior to study entry and throughout the study.

You may not qualify if:

• Subjects who do not have bipolar disorder by DSM-IV-TR criteria.
• Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
• Subjects whose bipolar manic symptoms are presently less than mild (CGI-BP \< 2) or more than markedly ill (CGI-BP \> 5 or YMRS \> 21)
• Subjects who have severe depressive symptoms (IDS \> 39 ) or psychotic features (as defined in DSM-IV)
• Subjects with clinically significant suicidal or homicidal ideation.
• Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance use disorder within the past six months; a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
• Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement \> 3 months.
• Subjects who are allergic to or who have demonstrated hypersensitivity to quetiapine.
• Women who are pregnant or nursing.
• Subjects who have received an experimental drug or used an experimental device within 30 days.
• Subjects who have a history of neuroleptic malignant syndrome.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• AstraZeneca: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0559, United States

Location

Related Publications (1)

• McElroy SL, Martens BE, Winstanley EL, Creech R, Malhotra S, Keck PE Jr. Placebo-controlled study of quetiapine monotherapy in ambulatory bipolar spectrum disorder with moderate-to-severe hypomania or mild mania. J Affect Disord. 2010 Jul;124(1-2):157-63. doi: 10.1016/j.jad.2009.11.014. Epub 2009 Dec 5.

  PMID: 19963274 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Susan L. McElroy, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 16, 2006
• Study Start: February 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 13, 2009

Record last verified: 2009-03

Locations

US (1)