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

NCT01172652

Last updated date
Study Location
VA Palo Alto Health Care System & Stanford School of Medicine
Palo Alto, California, 94304, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder, Panic Disorder, Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must at least age of 18 years of age 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria (26).


- Subjects who do not have lifetime panic disorder or generalized anxiety disorder 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 including hepatic, renal, respiratory,
cardiovascular, endocrine, neurological, or hematological disease 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%


- Admitted to hospital for treatment of DM or DM related illness within the past 12
weeks


- Not under physician care for DM


- Physician responsible for patient's DM care has not indicated that the patient's
DM is controlled


- Physician responsible for patient's DM care has not approved the patient's
participation in the study


- Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4
weeks before randomization. For thiazolidinediones(glitazones)this period should
not be less than 8 weeks before randomization.


- Taking insulin whose daily dose on one occasion in the past 4 weeks has been more
than 10% above or below their mean dose in the preceding 4 weeks


Note: If a patient with DM meets one of these criteria, the patient is to be excluded even
if the treating physician believes that the patient is stable and can participate in the
study

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Bipolar Disorder, Panic Disorder, Generalized Anxiety DisorderZiprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)
NCT01172652
  1. Palo Alto, California
  2. Tampa, Florida
  3. Mason, Ohio
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder
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.
Detailed Description This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of ziprasidone compared to placebo in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximately 50 subjects will be randomized. Subjects will be randomized to ziprasidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed throughout the study except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the management of insomnia and benztropine for the management of EPS. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.
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
  • Bipolar Disorder
  • Panic Disorder
  • Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: Ziprasidone
    The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.
    Other Names:
    • Geodon
    • Zeldox
  • Drug: Placebo
    Inactive control
    Other Name: sugar pill
Study Arms  ICMJE
  • Experimental: ziprasidone
    Intervention: Drug: Ziprasidone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
49
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2010)
50
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must at least age of 18 years of age 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.

Exclusion Criteria:

  • Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria (26).
  • Subjects who do not have lifetime panic disorder or generalized anxiety disorder 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 including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease 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%
    • Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks
    • Not under physician care for DM
    • Physician responsible for patient's DM care has not indicated that the patient's DM is controlled
    • Physician responsible for patient's DM care has not approved the patient's participation in the study
    • Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones(glitazones)this period should not be less than 8 weeks before randomization.
    • Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks

Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01172652
Other Study ID Numbers  ICMJE SUP0005-17504
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party patricia suppes, VA Palo Alto Health Care System
Study Sponsor  ICMJE VA Palo Alto Health Care System
Collaborators  ICMJE
  • Pfizer
  • University of South Florida
  • Lindner Center of HOPE
Investigators  ICMJE
Principal Investigator:Trisha Suppes, MD, PhDVA Palo Alto Health Care System & Stanford School of Medicine
PRS Account VA Palo Alto Health Care System
Verification Date March 2012

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