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.
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
- Conditions the study is for
- Bipolar Disorder, Panic Disorder, Generalized Anxiety Disorder
- 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
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 group | Role | What they receive |
|---|---|---|
| ziprasidone | Experimental | Ziprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. Receives: Drug: Ziprasidone |
| Placebo | Placebo comparator | Administered 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.
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)
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
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
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
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
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
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.
- First posted30 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Pfizer, University of South Florida, Lindner Center of HOPE
- Responsible party
- Principal investigator, patricia suppes, VA Palo Alto Health Care System
- Investigators
- Trisha Suppes, MD, PhD, Principal investigator, VA Palo Alto Health Care System & Stanford School of Medicine
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT01172652
- Acronym / sponsor ID
- PfizerAnxty / SUP0005-17504
- Keywords
- Bipolar disorder, Anxiety, Panic, GAD, Generalized Anxiety Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- Pfizer, University of South Florida, Lindner Center of HOPE
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ziprasidone | Experimental | Drug: ZiprasidoneZiprasidone in the form of 40 and/or 80 mg capsules. Dose range: 40 to 160 mg/day. |
| Placebo | Placebo comparator | Drug: PlaceboAdministered in capsules identical to the ziprasidone capsules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZiprasidoneAlso: Geodon, ZeldoxThe minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day. | Drug | ziprasidone |
| PlaceboAlso: sugar pillInactive control | Drug | Placebo |
Primary outcome
Clinician Global Improvement Scale (CGI-21)
Time frame: 8 weeks
CGI-21 Anxiety Scale ranges from -10 (Very Bad. Could not be worse) to +10 (Major Improvement. Back to normal self).
6 secondary outcomes
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 8 weeks
Young Mania Rating Scale
Time frame: 8 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 8 weeks
CGI-BP
Time frame: 8 weeks
Sheehan Disability Scale (SDS)
Time frame: 8 weeks
Sheehan Irritability Scale (SIS)
Time frame: 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24345758Suppes 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.
- Bipolar and Depression Research ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trisha Suppes, MD, PhD principal investigator
VA Palo Alto Health Care System & Stanford School of Medicine
3 sites in 1 country: see every site and its status.
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.