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Bipolar DisorderPhase 3NCT00312494

3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

A Phase 3 study testing Ziprasidone in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 66 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

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder
What is being tested?
Ziprasidone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
680 participants
Where
66 sitesUnited States
Study dates
Apr 2006to Dec 2008
Phase
Phase 3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).
  • At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
  • Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.

Who cannot join

  • Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (DSM-IV TR) diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (NOS) (298.9).
  • Subjects with other DSM-IV-TR Axis I or Axis II disorders (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6-month period prior to screening.

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Pfizer Investigational Site

    Amityville, New York, 11701

  • Pfizer Investigational Site

    Atlanta, Georgia, 30308

  • Pfizer Investigational Site

    Bellevue, Washington, 98004

  • Pfizer Investigational Site

    Buffalo, New York, 14215

  • Pfizer Investigational Site

    Cedarhurst, New York, 11516

  • Pfizer Investigational Site

    Cerritos, California, 90703

  • Pfizer Investigational Site

    Charleston, South Carolina, 29405

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45219

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45220

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45267-0559

  • Pfizer Investigational Site

    Clementon, New Jersey, 08021

  • Pfizer Investigational Site

    Cleveland, Ohio, 44113

  • Pfizer Investigational Site

    Costa Mesa, California, 92626

  • Pfizer Investigational Site

    Dallas, Texas, 75228

  • Pfizer Investigational Site

    DeLand, Florida, 32720

  • Pfizer Investigational Site

    Des Plaines, Illinois, 60016

  • Pfizer Investigational Site

    Dothan, Alabama, 36303

  • Pfizer Investigational Site

    Elmsford, New York, 10523

  • Pfizer Investigational Site

    Escondido, California, 92025

  • Pfizer Investigational Site

    Flowood, Mississippi, 39232

  • Pfizer Investigational Site

    Fort Lauderdale, Florida, 33301

  • Pfizer Investigational Site

    Fort Lauderdale, Florida, 33308

  • Pfizer Investigational Site

    Gainesville, Florida, 32607

  • Pfizer Investigational Site

    Glen Burnie, Maryland, 21061

  • Pfizer Investigational Site

    Glendale, California, 91204

  • Pfizer Investigational Site

    Greenwood, Indiana, 46143

  • Pfizer Investigational Site

    Hartford, Connecticut, 06106

  • Pfizer Investigational Site

    Hoffman Estates, Illinois, 60169

  • Pfizer Investigational Site

    Hoffman Estates, Illinois, 60194

  • Pfizer Investigational Site

    Hollywood, Florida, 33021

  • Pfizer Investigational Site

    Honolulu, Hawaii, 96813

  • Pfizer Investigational Site

    Huntington Beach, California, 92647

  • Pfizer Investigational Site

    Irving, Texas, 75062

  • Pfizer Investigational Site

    Jacksonville, Florida, 32256-2006

  • Pfizer Investigational Site

    Kansas City, Missouri, 64133

  • Pfizer Investigational Site

    Kirkland, Washington, 98033

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89102

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89103

  • Pfizer Investigational Site

    Lauderhill, Florida, 33119

  • Pfizer Investigational Site

    Little Rock, Arkansas, 72211

  • Pfizer Investigational Site

    Los Angeles, California, 90057

  • Pfizer Investigational Site

    Los Angeles, California, 90061

  • Pfizer Investigational Site

    National City, California, 91950

  • Pfizer Investigational Site

    New Britain, Connecticut, 06050

  • Pfizer Investigational Site

    North Miami, Florida, 33161

  • Pfizer Investigational Site

    Oceanside, California, 92056

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73112

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19149

  • Pfizer Investigational Site

    Plano, Texas, 75024

  • Pfizer Investigational Site

    Prairie Village, Kansas, 66206

  • Pfizer Investigational Site

    Princeton, New Jersey, 08540

  • Pfizer Investigational Site

    Raleigh, North Carolina, 27609

  • Pfizer Investigational Site

    Richmond, Virginia, 23229

  • Pfizer Investigational Site

    Richmond, Virginia, 23230

  • Pfizer Investigational Site

    Saint Charles, Missouri, 63304

  • Pfizer Investigational Site

    San Antonio, Texas, 78229-3900

  • Pfizer Investigational Site

    San Antonio, Texas, 78259-3509

  • Pfizer Investigational Site

    San Diego, California, 92114

  • Pfizer Investigational Site

    San Diego, California, 92120

  • Pfizer Investigational Site

    San Diego, California, 92126

  • Pfizer Investigational Site

    Schaumburg, Illinois, 60194

  • Pfizer Investigational Site

    Scottsdale, Arizona, 85251

  • Pfizer Investigational Site

    St Louis, Missouri, 63044-2588

  • Pfizer Investigational Site

    St Louis, Missouri, 63118

  • Pfizer Investigational Site

    St Louis, Missouri, 63128

  • Pfizer Investigational Site

    Torrance, California, 90505

Other trials in United States

About this study

Official title: A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral Ziprasidone in Subjects With Acute Mania Treated With Lithium or Divalproex

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects

Being tested
Placebo, Ziprasidone
Medical subject headings
Bipolar Disorder

What participants receive

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

  • PlaceboDrug

    Placebo with mood stabilizer (either lithium or divalproex)

  • ZiprasidoneDrug

    Also called Geodon, Zeldox

    Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)

  • ZiprasidoneDrug

    Also called Geodon, Zeldox

    Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)

Study groups in NCT00312494
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Ziprasidone 20-40mg twice a day (BID)ExperimentalNot described
Receives: Drug: Ziprasidone
Ziprasidone 60-80mg BIDExperimentalNot described
Receives: Drug: Ziprasidone

What is being measured

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

  1. Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)

    YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).

    Measured: Baseline, Week 3

Secondary outcomes (8)

  1. Change From Baseline to Week 1 and Week 2 in YMRS

    YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).

    Measured: Baseline, Week 1, Week 2

  2. Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores

    MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value).

    Measured: Baseline, Week 1, Week 2, Week 3

  3. Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score

    CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value).

    Measured: Baseline, Week 1, Week 2, Week 3

  4. Clinical Global Impression - Improvement (CGI-I) Scale Scores

    CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected.

    Measured: Week 1, Week 2, Week 3

  5. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score

    PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value).

    Measured: Baseline, Week 3

  6. Change From Baseline in Global Assessment of Functioning (GAF) Score

    GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value).

    Measured: Baseline, Week 3

  7. Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score

    LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value).

    Measured: Baseline, Week 3

  8. Anonymized Pharmacogenomic Blood Draw

    Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity.

    Measured: Baseline

Timeline

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

  1. First posted10 Apr 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionDec 2008
  4. Study completionDec 2008

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
680 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00312494
Sponsor's protocol ID
A1281143
Status last verified
Mar 2021
First submitted
6 Apr 2006
Last updated
29 Mar 2021
Data monitoring committee
No

Publications

  • Sachs GS, Vanderburg DG, Edman S, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 2: influence of protocol-specific eligibility criteria on signal detection. J Clin Psychiatry. 2012 Nov;73(11):1420-5. doi: 10.4088/JCP.11m07389.

    PubMed 23218158

  • Sachs GS, Vanderburg DG, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 1: results of a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2012 Nov;73(11):1412-9. doi: 10.4088/JCP.11m07388.

    PubMed 23218157

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ziprasidone in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 66 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 3 inclusion and 2 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 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Jan 2010). 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?

Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) (time frame: Baseline, Week 3). 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 NCT00312494, which also lists 2 linked publications.

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 29 Mar 2021.

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