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

NCT00374543 | Terminated Phase 4 Results DMC

• 1 other identifier: 2006-P-000142
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder; Bipolar Disorder

Keywords

Bipolar Disorder; Generalized Anxiety Disorder; Double-blind; Placebo-controlled; Ziprasidone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clinical Global Impression of Improvement (CGI-I)

  8 weeks

Study Arms (2)

Ziprasidone

EXPERIMENTAL

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.

Drug: Ziprasidone

Placebo Capsules

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Ziprasidone DRUG

Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.

Also known as: Geodon

Ziprasidone

Placebo DRUG

Placebo administered daily for 8 weeks

Also known as: Control

Placebo Capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pfizer: collaborator

Study Sites (1)

Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Limitations and Caveats

This study was terminated due to extreme difficulties in participant recruitment. Therefore, the sample size is extremely low, leaving inconclusive data.

Results Point of Contact

• Title: Naomi M. Simon, M.D., M.Sc.
• Organization: Massachusetts General Hospital

nsimon@partners.org

(617) 726-7913

Study Officials

• Naomi M. Simon, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Anxiety and Traumatic Stress Disorders

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: February 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2008
• Last Updated: April 16, 2014
• Results First Posted: April 16, 2014

Record last verified: 2014-03

Locations

US (1)