Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)

NCT01172652 | Completed Phase 4 Results DMC

• 1 other identifier: SUP0005-17504
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

Brief Summary

The specific aim of this study is to evaluate the efficacy, tolerability, and safety of ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.

Conditions

Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder

Keywords

Bipolar disorder; Anxiety; Panic; GAD; Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Clinician Global Improvement Scale (CGI-21)

  CGI-21 Anxiety Scale ranges from -10 (Very Bad. Could not be worse) to +10 (Major Improvement. Back to normal self).

  8 weeks

Secondary Outcomes (6)

• Hamilton Anxiety Rating Scale (HAM-A)

  8 weeks

• Young Mania Rating Scale

  8 weeks

• Montgomery-Asberg Depression Rating Scale (MADRS)

  8 weeks

• CGI-BP

  8 weeks

• Sheehan Disability Scale (SDS)

  8 weeks

Study Arms (2)

ziprasidone

EXPERIMENTAL

Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day.

Drug: Ziprasidone

Placebo

PLACEBO COMPARATOR

Administered in capsules identical to the ziprasidone capsules.

Drug: Placebo

Interventions

Ziprasidone DRUG

The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.

Also known as: Geodon, Zeldox

ziprasidone

Placebo DRUG

Inactive control

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be at least 18 and not older than 65.
• Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR criteria (26).
• Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD).
• Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP\< 4 (27).
• Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S \> 4 (28).
• Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline.
• Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
• If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.

You may not qualify if:

• Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria (26).
• Subjects who do not have lifetime panic disorder or GAD by DSM-IV-TR criteria (26).
• Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
• Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP \> 5) (27).
• Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S \< 3) (28).
• Subjects with clinically significant suicidal or homicidal ideation.
• Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
• Subjects with serious general medical illnesses as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement \> 3 months.
• Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests.
• Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to ziprasidone.
• Women who are pregnant or nursing.
• Subjects who have received an experimental drug or used an experimental device within 30 days.
• Subjects who have a history of neuroleptic malignant syndrome.
• A patient with diabetes mellitus (DM) fulfilling one of the following criteria:
• Unstable DM defined as enrollment glycosylated hemoglobin (HbAlc) \>8.5%

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead
• Pfizer: collaborator
• University of South Florida: collaborator
• Lindner Center of HOPE: collaborator

Study Sites (3)

VA Palo Alto Health Care System & Stanford School of Medicine

Palo Alto, California, 94304, United States

Location

University of South Florida Institute for Research in Psychiatry

Tampa, Florida, 33613, United States

Location

Lindner Center of Hope University of Cincinnati Medical Center

Mason, Ohio, 45040, United States

Location

Related Publications (1)

• Suppes T, McElroy SL, Sheehan DV, Hidalgo RB, Cosgrove VE, Gwizdowski IS, Feldman NS. A randomized, double-blind, placebo-controlled study of ziprasidone monotherapy in bipolar disorder with co-occurring lifetime panic or generalized anxiety disorder. J Clin Psychiatry. 2014 Jan;75(1):77-84. doi: 10.4088/JCP.12m08297.

  PMID: 24345758 DERIVED

Related Links

• Bipolar and Depression Research Program

MeSH Terms

Conditions

Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder; Anxiety Disorders

Interventions

ziprasidone; Sugars

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Dr. Trisha Suppes, MD PhD
• Organization: VA Palo Alto Health Care System

tsuppes@va.gov

(650) 493-5000

Study Officials

• Trisha Suppes, MD, PhD

  VA Palo Alto Health Care System & Stanford School of Medicine

  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: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bipolar and Depression Research Program

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: July 30, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2017-06

Locations

US (3)