Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ziprasidone · 13 trials · 7 indications
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); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.
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).
YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.
CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).
number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.
Mean Change: lab value at observation minus lab value at baseline.
Mean Change: lab value at observation minus lab value at baseline
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean change; body weight value at observation minus body weight value at baseline.
mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.
QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.
| Arm | Type | Description |
|---|---|---|
| Ziprasidone | EXPERIMENTAL | Active treatment, double-blind, randomized treatment arm |
| Placebo | PLACEBO_COMPARATOR | Inactive, placebo treatment, double-blind, randomized arm |
| Ziprasidone 20-40mg twice a day (BID) | EXPERIMENTAL | - |
| Ziprasidone 60-80mg BID | EXPERIMENTAL | - |
| Open | EXPERIMENTAL | - |
| A | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| A1 | EXPERIMENTAL | - |
| Low-Dose Ziprasidone | ACTIVE_COMPARATOR | - |
| High-Dose Ziprasidone | ACTIVE_COMPARATOR | - |
| Geodon fed | ACTIVE_COMPARATOR | Commercial Geodon (ziprasidone) capsules given with food |
| B16 Fasted | EXPERIMENTAL | Experimental reduced food effect formulation given without food |
| B16 Fed | EXPERIMENTAL | Experimental reduced food effect formulation given with food |
| Name | Type | Description |
|---|---|---|
| Ziprasidone | DRUG | Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day. |
| Placebo | DRUG | Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm |
| Ziprasidone oral capsules | DRUG | Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid . |
| Ziprasidone Oral Capsule | DRUG | Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment. |
| Risperidone | DRUG | Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6 |
| Clozapine | DRUG | Clozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks |
| olanzapine | DRUG | - |
| B16 Fasted | DRUG | 40 mg tablet, single dose X 3 |
| B16 Fed | DRUG | 40 mg tablet, single dose X 3 |
Inclusion Criteria: * Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate o...
Ziprasidone is an investigational small molecule being studied for the treatment of Bipolar Mania, Bipolar Disorder, and Schizophrenia. It is also being evaluated in healthy volunteers. The drug is in Phase 3 clinical development for these psychiatric conditions.
Ziprasidone is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with bipolar disorder and schizophrenia.
Ziprasidone is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials are completed and were designed to assess the drug's efficacy and safety in treating bipolar mania, bipolar disorder, and schizophrenia.
Ziprasidone has completed eight Phase 3 clinical trials, including NCT00265330, NCT00280566, NCT00312494, and NCT00483548. These trials studied the drug in children, adolescents, and adults with bipolar disorder, bipolar mania, and bipolar depression. All trials were randomized, double-blind, and placebo-controlled.
Ziprasidone is the generic name for the drug also known as Geodon. The clinical trials listed under the name Ziprasidone evaluate this antipsychotic medication for the treatment of bipolar disorder and schizophrenia.