Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Ziprasidone for the Treatment of Generalized Anxiety Comorbidity in Patients With Bipolar Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00374543
• Other study ID #: 2006-P-000142
• Status: Terminated
• Phase: Phase 4
• First received: September 8, 2006
• Last updated: March 20, 2014
• Start date: February 2006
• Est. completion date: November 2008

Study information

• Verified date: March 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Disorder
• Disease
• Generalized Anxiety Disorder

Intervention

Drug:
• Ziprasidone
Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.
• Placebo
Placebo administered daily for 8 weeks

Locations

Country	Name	City	State
United States	Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	No
Secondary	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.	8 weeks	No