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Trial record 1 of 1 for:    NCT00374543
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Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00374543
Recruitment Status : Terminated (Recruitment goal could not be achieved)
First Posted : September 11, 2006
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE September 8, 2006
First Posted Date  ICMJE September 11, 2006
Results First Submitted Date  ICMJE May 20, 2013
Results First Posted Date  ICMJE April 16, 2014
Last Update Posted Date April 16, 2014
Study Start Date  ICMJE February 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 8 weeks ]
The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD. Due to study termination, there are not results for primary and secondary outcome measures.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2006)
HAM-A rating scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 8 weeks ]
A secondary categorical outcome of response will be defined as a Clinical Global Impression Improvement Score (CGI-I) of 1 or 2. The CGI-I is a 7 point clinician-rated scale that assesses symptom improvement or worsening relative to a previous assessment. Lower ratings reflect greater improvement. Due to study termination, there are not results for primary and secondary outcome measures.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2006)
  • CGI-S
  • CGI-I
  • LIFE-RIFT
  • MADRS
  • YMRS
  • Q-LES-Q
  • QIDS-SR
  • CD-RISC
  • ASI
  • PSS
  • Life Experiences Survey
  • PSQI
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder
Official Title  ICMJE Ziprasidone for the Treatment of Generalized Anxiety Comorbidity in Patients With Bipolar Disorder
Brief Summary This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of quality of life and resilience.
Detailed Description

This study would be the first prospective, placebo-controlled study to our knowledge of any pharmacotherapy strategy for the treatment of comorbid generalized anxiety (or any comorbid anxiety) in patients with bipolar disorder. Our hypotheses are:

  1. Ziprasidone flexibly dosed from 40 to 160 mg/day will reduce anxiety symptoms significantly more than placebo in patients with bipolar disorder who have a full or subsyndromal diagnosis of generalized anxiety disorder (GAD).
  2. Ziprasidone will be well tolerated in patients with generalized anxiety based on the incidence of treatment emergent adverse effects during 8 weeks of therapy, and based on a lack of worsening of bipolar depression, mania or hypomania compared to placebo.
  3. Treatment with ziprasidone will have a significantly greater positive impact on measures of quality of life and resilience than placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Generalized Anxiety Disorder
  • Bipolar Disorder
Intervention  ICMJE
  • Drug: Ziprasidone
    Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.
    Other Name: Geodon
  • Drug: Placebo
    Placebo administered daily for 8 weeks
    Other Name: Control
Study Arms  ICMJE
  • Experimental: Ziprasidone
    Ziprasidone will be dosed on a twice daily (BID) basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day, for 8 weeks. This time period reflects the rapid onset of effect seen in studies of atypical antipsychotics, but allows time for a potentially longer response for some anxiety symptoms.
    Intervention: Drug: Ziprasidone
  • Placebo Comparator: Placebo Capsules
    Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 20, 2014)
3
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female outpatients, aged 18 to 75 years.
  • Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II).
  • Current diagnosis of Generalized Anxiety Disorder (GAD).
  • Participants must be on at least one of the following mood stabilizers at steady dose for at least 4 weeks prior to randomization: lithium with blood levels between 0.4-1.4 meq/L, valproic acid/divalproate sodium (with levels between 50-150 ugm/dl) carbamazepine (blood levels between 4-12 mcg/ml), or lamotrigine (dosed 50-400 mg/day).

Exclusion Criteria:

  • Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).
  • Patients with current or history of schizophrenia, or patients with current mania, hypomania at study entry. Lifetime psychosis and dementia are exclusionary.
  • Patients with current obsessive-compulsive disorder or posttraumatic stress disorder are excluded.
  • Patients with a history of alcohol or substance abuse or dependence within the last three months.
  • Patients with significant unstable medical illness likely to result in hospitalization or acute medical care. In addition, patients with an established diagnosis of diabetes mellitus are excluded.
  • Current cognitive behavioral therapy directed toward the treatment of generalized anxiety disorder.
  • History of hypersensitivity to or lack of response to ziprasidone.
  • Concomitant treatment with other typical or atypical antipsychotics; patients should be off other typical or atypical antipsychotics for at least one week prior to study baseline.
  • Patients with significant suicidal ideation or who have enacted suicidal behaviors within 3 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
  • Patients who have had a psychiatric hospitalization (including for bipolar disorder) in the past 3 months are excluded.
  • Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood, were isolated, and did not recur in adulthood.
  • History of Neuroleptic Malignant Syndrome.
  • Individuals with current clinically significant orthostatic hypotension are excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00374543
Other Study ID Numbers  ICMJE 2006-P-000142
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Naomi M. Simon, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Naomi M. Simon, M.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP