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

NCT00671853 | Completed Phase 3 Results DMC

• 1 other identifier: 10-06-19
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Disorder; Anxiety; Anxiety Disorders; Substance Use Disorders

Keywords

Bipolar Disorder; Anxiety; Anxiety Disorders; Substance Use Disorders

Outcome Measures

Primary Outcomes (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.

  Week 0 - Week 8

Secondary Outcomes (5)

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

  Week 0 - Week 8

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

  Week 0 - Week 8

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

  Week 0 - Week 8

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

  Week 0 - Week 8

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

  Week 0 - Week 8

Study Arms (2)

1

EXPERIMENTAL

Quetiapine XR

Drug: Quetiapine XR

2

PLACEBO COMPARATOR

Placebo for quetiapine XR

Drug: Placebo for quetiapine XR

Interventions

Quetiapine XR DRUG

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

Also known as: Seroquel XR

1

Placebo for quetiapine XR DRUG

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

Also known as: Placebo for Seroquel XR

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator
• AstraZeneca: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 25007003 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Anxiety Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Kemp Gao
• Organization: University Hospitals Cleveland Medical Center

keming.gao@UHhopsitals.org

216-844-2865

Study Officials

• Keming Gao, PhD, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mood & Anxiety Clinic

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 29, 2016
• Results First Posted: October 11, 2013

Record last verified: 2016-11

Locations

US (1)