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Bipolar DisorderPhase 4PfizerAnxtyNCT01172652

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

A Phase 4 study testing Ziprasidone in people with Bipolar Disorder and Panic Disorder, run by VA Palo Alto Health Care System at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Ziprasidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
3 sitesUnited States
Study dates
Apr 2010to Oct 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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%
  • 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 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Lindner Center of Hope University of Cincinnati Medical Center

    Mason, Ohio, 45040

  • VA Palo Alto Health Care System & Stanford School of Medicine

    Palo Alto, California, 94304

  • University of South Florida Institute for Research in Psychiatry

    Tampa, Florida, 33613

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder

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.

Read the 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.

Being tested
Ziprasidone, Placebo
Keywords
Bipolar disorder, Anxiety, Panic, GAD, Generalized Anxiety Disorder
Medical subject headings
Bipolar Disorder, Panic Disorder, Generalized Anxiety Disorder, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZiprasidoneDrug

    Also called Geodon, Zeldox

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

  • PlaceboDrug

    Also called sugar pill

    Inactive control

Study groups in NCT01172652
Study groupRoleWhat they receive
ziprasidoneExperimentalZiprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day.
Receives: Drug: Ziprasidone
PlaceboPlacebo comparatorAdministered in capsules identical to the ziprasidone capsules.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 8 weeks

Secondary outcomes (6)
  1. Hamilton Anxiety Rating Scale (HAM-A)

    Scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

    Measured: 8 weeks

  2. Young Mania Rating Scale

    Four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. The authors encourage the use of whole or half point ratings once experience with the scale is acquired. Typical YMRS baseline scores can vary a lot. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).

    Measured: 8 weeks

  3. Montgomery-Asberg Depression Rating Scale (MADRS)

    Ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are: 0 to 6 - normal /symptom absent; 7 to 19 - mild depression; 20 to 34 moderate depression; >34 - severe depression.

    Measured: 8 weeks

  4. CGI-BP

    A guide for rating severity of manic and depressive episodes and the degree of change from the immediately preceding phase and from the worst phase of illness. Provides a set of instructions to facilitate the reliability of these ratings of mania, depression, and overall bipolar illness during treatment of an acute episode or in longer-term illness prophylaxis. Comprises two companion one-item measures evaluating the following:(a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. The minimum value in each category is a score of 1 (indicating 'normal' or 'not ill') and the maximum value is a score of 7 (indicating 'very severely ill'). Higher scores indicate a worse outcome due to greater severity of bipolar symptoms. 1 = Very much improved 5 = Minimally worse 2 = Much improved 6 = Much worse 3 = Minimally improved 7 = Very much worse 4 = No change 3. Efficacy Index Rate this item on the basis of drug effect only.

    Measured: 8 weeks

  5. Sheehan Disability Scale (SDS)

    A composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by panic, anxiety, phobic, or depressive symptoms. Patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. In each sector of the overall scale, the minimum score is a 1 (indicating that symptoms have been 'not at all' disruptive to functioning) and the maximum score is a 10 (indicating that symptoms have been 'extremely' disruptive to functioning). Each area of functioning is rated on a scale of 0 to either 3 or 5 (maximum score = 29-extreme vegetative state, minimum score = 0-person without disability) with the highest scores representing the higher level of disability. Higher scores indicate a worse outcome stemming from greater disability/impairment.

    Measured: 8 weeks

  6. Sheehan Irritability Scale (SIS)

    SIS consists of seven items that assess symptoms of irritability, frustration, edginess/impatience, moodiness, anger with self, anger with others and temper during the previous week. Each item is assessed on an 11-point numeric rating scale ranging from 0 (not at all) to 10 (extremely). The SIS total score is calculated by summing of the scores for each of the seven individual items and ranges from 0 to 70. A higher score indicates a higher rate of irritability symptoms and therefore, a worse outcome.

    Measured: 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01172652
Sponsor's protocol ID
SUP0005-17504
Acronym
PfizerAnxty
Status last verified
Jun 2017
First submitted
16 Apr 2010
Last updated
8 Apr 2025
Data monitoring committee
Yes
Individual data sharing
Undecided

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.

    PubMed 24345758

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ziprasidone in people with Bipolar Disorder and Panic Disorder, run by VA Palo Alto Health Care System at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician Global Improvement Scale (CGI-21) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01172652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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PfizerAnxty Clinical Trial NCT01172652 | AzTrials