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3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Ziprasidone 20-40mg twice a day (BID) | Experimental |
| |
| Ziprasidone 60-80mg BID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo with mood stabilizer (either lithium or divalproex) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Dothan | Alabama | 36303 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23218158 | Derived | 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. | |
| 23218157 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziprasidone (Higher Dose) | Ziprasidone 120 to 160 mg daily + Mood Stabilizer |
| FG001 | Ziprasidone (Lower Dose) | Ziprasidone 40 to 80 mg daily + Mood Stabilizer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Ziprasidone |
| Drug |
Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex) |
|
|
| Ziprasidone | Drug | Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex) |
|
|
| Baseline, Week 1, Week 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). | Baseline, Week 1, Week 2, Week 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). | Baseline, Week 1, Week 2, Week 3 |
| 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. | Week 1, Week 2, Week 3 |
| 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). | Baseline, Week 3 |
| 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). | Baseline, Week 3 |
| 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). | Baseline, Week 3 |
| Anonymized Pharmacogenomic Blood Draw | Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity. | Baseline |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72211 | United States |
| Pfizer Investigational Site | Cerritos | California | 90703 | United States |
| Pfizer Investigational Site | Costa Mesa | California | 92626 | United States |
| Pfizer Investigational Site | Escondido | California | 92025 | United States |
| Pfizer Investigational Site | Glendale | California | 91204 | United States |
| Pfizer Investigational Site | Huntington Beach | California | 92647 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90057 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90061 | United States |
| Pfizer Investigational Site | National City | California | 91950 | United States |
| Pfizer Investigational Site | Oceanside | California | 92056 | United States |
| Pfizer Investigational Site | San Diego | California | 92114 | United States |
| Pfizer Investigational Site | San Diego | California | 92120 | United States |
| Pfizer Investigational Site | San Diego | California | 92126 | United States |
| Pfizer Investigational Site | Torrance | California | 90505 | United States |
| Pfizer Investigational Site | Hartford | Connecticut | 06106 | United States |
| Pfizer Investigational Site | New Britain | Connecticut | 06050 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | Fort Lauderdale | Florida | 33301 | United States |
| Pfizer Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32607 | United States |
| Pfizer Investigational Site | Hollywood | Florida | 33021 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32256-2006 | United States |
| Pfizer Investigational Site | Lauderhill | Florida | 33119 | United States |
| Pfizer Investigational Site | North Miami | Florida | 33161 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | United States |
| Pfizer Investigational Site | Honolulu | Hawaii | 96813 | United States |
| Pfizer Investigational Site | Des Plaines | Illinois | 60016 | United States |
| Pfizer Investigational Site | Hoffman Estates | Illinois | 60169 | United States |
| Pfizer Investigational Site | Hoffman Estates | Illinois | 60194 | United States |
| Pfizer Investigational Site | Schaumburg | Illinois | 60194 | United States |
| Pfizer Investigational Site | Greenwood | Indiana | 46143 | United States |
| Pfizer Investigational Site | Prairie Village | Kansas | 66206 | United States |
| Pfizer Investigational Site | Glen Burnie | Maryland | 21061 | United States |
| Pfizer Investigational Site | Flowood | Mississippi | 39232 | United States |
| Pfizer Investigational Site | Kansas City | Missouri | 64133 | United States |
| Pfizer Investigational Site | Saint Charles | Missouri | 63304 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63044-2588 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63118 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63128 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89103 | United States |
| Pfizer Investigational Site | Clementon | New Jersey | 08021 | United States |
| Pfizer Investigational Site | Princeton | New Jersey | 08540 | United States |
| Pfizer Investigational Site | Amityville | New York | 11701 | United States |
| Pfizer Investigational Site | Buffalo | New York | 14215 | United States |
| Pfizer Investigational Site | Cedarhurst | New York | 11516 | United States |
| Pfizer Investigational Site | Elmsford | New York | 10523 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45220 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45267-0559 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44113 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19149 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29405 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75228 | United States |
| Pfizer Investigational Site | Irving | Texas | 75062 | United States |
| Pfizer Investigational Site | Plano | Texas | 75024 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229-3900 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78259-3509 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23229 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23230 | United States |
| Pfizer Investigational Site | Bellevue | Washington | 98004 | United States |
| Pfizer Investigational Site | Kirkland | Washington | 98033 | United States |
| 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. |
| FG002 | Placebo | Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer |
| Received Study Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ziprasidone (Higher Dose) | Ziprasidone 120 to 160 mg daily + Mood Stabilizer |
| BG001 | Ziprasidone (Lower Dose) | Ziprasidone 40 to 80 mg daily + Mood Stabilizer |
| BG002 | Placebo | Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intent to Treat population (ITT): all randomized subjects who received at least 1 dose of double-blind medication, who had 1 baseline and at least 1 post-baseline primary efficacy evaluation; excluding data from 2 sites that were closed due to Good Clinical Practices (GCP) deviations. | Posted | Least Squares Mean | Standard Error | scores on scale | Baseline, Week 3 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT population excluding data from 2 sites that were closed to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | Posted | Least Squares Mean | Standard Error | scores on scale | Baseline, Week 1, Week 2 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | Posted | Least Squares Mean | Standard Error | scores on scale | Baseline, Week 1, Week 2, Week 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | Posted | Least Squares Mean | Standard Error | scores on scale | Baseline, Week 1, Week 2, Week 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | Posted | Least Squares Mean | Standard Error | scores on scale | Week 1, Week 2, Week 3 |
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| Secondary | 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). | ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | Posted | Least Squares Mean | Standard Error | scores on scale | Baseline, Week 3 |
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| Secondary | 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). | ITT population excluding data from 2 sites that were closed due to GCP deviations. | Posted | Least Squares Mean | Standard Error | scores on scale | Baseline, Week 3 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT population excluding data from 2 sites that were closed due to GCP deviations. | Posted | Least Squares Mean | Standard Error | scores on scale | Baseline, Week 3 |
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| Secondary | Anonymized Pharmacogenomic Blood Draw | Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity. | All subjects eligible (optional consent); samples were not to be analyzed as part of the current protocol and the analysis was not to be covered by the statistical analysis plan. | Posted | Baseline |
|
|
Not provided
Safety population: all randomized subjects who were administered at least 1 dose of double-blind medication; includes data from the 2 sites that were closed due to GCP deviations.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ziprasidone (Higher Dose) | Ziprasidone 120 to 160 mg daily + Mood Stabilizer | 5 | 223 | 134 | 223 | ||
| EG001 | Ziprasidone (Lower Dose) | Ziprasidone 40 to 80 mg daily + Mood Stabilizer | 4 | 216 | 99 | 216 | ||
| EG002 | Placebo | Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer | 4 | 217 | 82 | 217 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Anterograde amnesia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Emotional disorder | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Restlessness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C092292 | ziprasidone |
Not provided
Not provided
Not provided
| Between 18 and 44 years |
|
| Between 45 and 64 years |
|
| >=65 years |
|
| Male |
|
| Superiority or Other (legacy) |
| Week 3 Mixed Model Repeated Measures (MMRM) with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score. Tests were 2-sided and performed at the 0.05 significance level. | Mixed Models Analysis | 0.4274 | The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3. | 95 | Superiority or Other (legacy) |
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