Back to resultsZiprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder
Primary Purpose
Generalized Anxiety Disorder, Bipolar Disorder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ziprasidone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Bipolar Disorder, Generalized Anxiety Disorder, Double-blind, Placebo-controlled, Ziprasidone
Eligibility Criteria
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.
Sites / Locations
- Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ziprasidone
Placebo Capsules
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Hamilton Anxiety Rating Scale (HAM-A)
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.
Secondary Outcome Measures
Clinical Global Impression of Improvement (CGI-I)
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.
Full Information
NCT ID
NCT00374543
First Posted
September 8, 2006
Last Updated
March 20, 2014
Sponsor
Massachusetts General Hospital
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00374543
Brief Title
Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder
Official Title
Ziprasidone for the Treatment of Generalized Anxiety Comorbidity in Patients With Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Recruitment goal could not be achieved
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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).
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.
Treatment with ziprasidone will have a significantly greater positive impact on measures of quality of life and resilience than placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Bipolar Disorder
Keywords
Bipolar Disorder, Generalized Anxiety Disorder, Double-blind, Placebo-controlled, Ziprasidone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ziprasidone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Capsules
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon
Intervention Description
Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Placebo administered daily for 8 weeks
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale (HAM-A)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression of Improvement (CGI-I)
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi M. Simon, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder
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