Trial · NCT02075047
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
NCT02075047, Phase 3, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2021-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder. Trials, record NCT02075047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02075047
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
- NCT number
- NCT02075047
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 171 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Bipolar Disorder
- Interventions
- placebo oral capsules, ziprasidone oral capsules
- First posted
- 2014-03-03
- Last updated
- 2021-06-16
- Results first posted
- 2021-04-01
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4 | Baseline, Week 4 | YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania. |
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Baseline, Week 1, 2, 3, 4 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill), higher scores indicated more severity of illness. |
| Secondary | Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3 | Baseline, Week 1, 2, 3 | YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania. |
| Secondary | Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4 | Baseline, Week 1, 2, 3, 4 | CGI-I: 7-point clinician rated scale which rates the participant's improvement or worsening from baseline, ranging from 1 (very much improved) to 7 (very much worse), higher scores indicate less improvement. |
| Other | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Screening (2 Weeks prior to Day 1) up to maximum of 5 Weeks after administration of the final dose of study medication (maximum up to 11 weeks) | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs. |
| Other | Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS) | Screening (2 Weeks prior to Day 1), Baseline (Day 1), Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9) | C-SSRS: a measure used to identify and assess participants at risk for suicide. It is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. C-SSRS items were mapped to the following C-CASA categories: completed suicide, attempted suicide (actual attempt; aborted attempt; interrupted attempt), non-suicidal self-injurious behavior, preparatory acts, suicidal ideation (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods \[not plan\], without intent to act; active suicidal ideation with some intent to act, without specific plan; active suicidal ideation with specific plan and intent; self-injurious behavior, no suicidal intent). Rows according to C-CASA categories at specified time points are reported in this outcome measure, only when there was non-zero data/values for at least 1 reporting arm. |
| Other | Number of Participants Who Took at Least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures | Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks) | Concomitant medications or treatments were those prescription and over-the-counter drugs and supplements or non drug treatment/procedures other than the study medication. |
| Other | Number of Participants With Laboratory Abnormalities | Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks) | Criteria: Hematology-hemoglobin(Hg),hematocrit,erythrocytes(ery)\<0.8\*LLN,ery mean corpuscular volume \<0.9\*LLN\>1.1\*ULN,platelets\<0.5\*LLN\>1.75\*ULN,leukocytes(leu)\<0.6\*LLN\>1.5\*ULN,lymphocytes(lym),lym/leu,neutrophils(neu),neu/leu\<0.8\*LLN\>1.2\*ULN,basophils (bas),bas/leu, eosinophils(eos), eos/leu, monocytes(mon),mon/leu\>1.2\*ULN; Clinical chemistry bilirubin: total, direct, indirect\>1.5\*ULN, aspartate aminotransferase,alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase,alkaline phosphatase\>3.0\*ULN,protein,albumin\<0.8\*LLN\>1.2\*ULN,blood urea nitrogen,creatinine\>1.3\*ULN, urate\>1.2\*ULN,HDL\<0.8\*LLN;LDL\>1.2\*ULN cholesterol(CH),sodium\<0.95\*LLN\>1.05\*ULN,potassium, chloride,calcium,magnesium,bicarbonate\<0.9\*LLLN\>1.1\*ULN,phosphate,free thyroxine,thyroid stimulating hormone\<0.8\*LLN\>1.2\*ULN,prolactin\>1.1\*ULN,glucose\<0.6\*LLN\>1.5\*ULN,HgA1C,CH, triglycerides\>1.3\*ULN,creatine kinase\>2.0\*ULN; Urinalysis-specific gravity\<1.003\>1.030,pH\<4.5 \>8,urine glucose, protein, Hg, ketones:\>=1. |
| Other | Number of Participants With Physical Examination Abnormalities | Screening (2 Weeks prior to Day 1) up to Week 4 | Parameters assessed for physical examination included: oral/tympanic temperature, general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts (if medically indicated), abdomen, external genitalia \[if medically indicated\], extremities, back/spinal system, lymph nodes or worsening of medical history conditions. Abnormality in physical examination was at the investigator's discretion. |
| Other | Change From Baseline in Blood Pressure at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit | Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9) | Change from baseline in sitting and standing systolic blood pressure and diastolic blood pressure in millimeter of mercury (mmHg) was reported. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4 | Baseline, Week 4 | Intent-to-treat (ITT) included all randomized participants who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and had at least 1 post-baseline visit. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Baseline, Week 1, 2, 3, 4 | ITT included all randomized participants who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and had at least 1 post-baseline visit. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3 | Baseline, Week 1, 2, 3 | ITT included all randomized participants who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and had at least 1 post-baseline visit. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4 | Baseline, Week 1, 2, 3, 4 | ITT included all randomized participants who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and had at least 1 post-baseline visit. | units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Screening (2 Weeks prior to Day 1) up to maximum of 5 Weeks after administration of the final dose of study medication (maximum up to 11 weeks) | The safety analysis set included all participants who were randomized and took at least 1 dose of study medication (ziprasidone or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS) | Screening (2 Weeks prior to Day 1), Baseline (Day 1), Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9) | ITT included all randomized participants who had baseline measurements, took at least 1 dose of study medication (ziprasidone or placebo) and had at least 1 post-baseline visit. Here 'number analyzed' signifies number of participants evaluable for each specified row. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Took at Least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures | Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks) | The safety analysis set included all participants who were randomized and took at least 1 dose of study medication (ziprasidone or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Laboratory Abnormalities | Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks) | The safety analysis set included all participants who were randomized and took at least 1 dose of study medication (ziprasidone or placebo). Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Physical Examination Abnormalities | Screening (2 Weeks prior to Day 1) up to Week 4 | The safety analysis set included all participants who were randomized and took at least 1 dose of study medication (ziprasidone or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline in Blood Pressure at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit | Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9) | The safety analysis set included all participants who were randomized and took at least 1 dose of study medication (ziprasidone or placebo). Here 'number analyzed' signifies number of participants evaluable for each specified row. | millimeter of mercury | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group244
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4 | Ziprasidone | -16.51 | Standard Error 1.15 | units on a scale | |
| Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4 | Placebo | -12.29 | Standard Error 1.10 | units on a scale | |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Ziprasidone | Change at Week 1 | -0.91 | Standard Error 0.10 | units on a scale |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Placebo | Change at Week 1 | -0.47 | Standard Error 0.10 | units on a scale |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Ziprasidone | Change at Week 2 | -1.13 | Standard Error 0.12 | units on a scale |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Placebo | Change at Week 2 | -0.91 | Standard Error 0.12 | units on a scale |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Ziprasidone | Change at Week 3 | -1.53 | Standard Error 0.13 | units on a scale |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Placebo | Change at Week 3 | -1.14 | Standard Error 0.13 | units on a scale |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Ziprasidone | Change at Week 4 | -1.59 | Standard Error 0.14 | units on a scale |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 | Placebo | Change at Week 4 | -1.32 | Standard Error 0.14 | units on a scale |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase (4 Weeks) | STARTED | Ziprasidone | 86 | |
| Treatment Phase (4 Weeks) | STARTED | Placebo | 85 | |
| Treatment Phase (4 Weeks) | COMPLETED | Ziprasidone | 63 | |
| Treatment Phase (4 Weeks) | COMPLETED | Placebo | 75 | |
| Treatment Phase (4 Weeks) | NOT COMPLETED | Ziprasidone | 23 | |
| Treatment Phase (4 Weeks) | NOT COMPLETED | Placebo | 10 | |
| Follow up Phase (5 Weeks) | STARTED | Ziprasidone | 86 | |
| Follow up Phase (5 Weeks) | STARTED | Placebo | 85 | |
| Follow up Phase (5 Weeks) | COMPLETED | Ziprasidone | 60 | |
| Follow up Phase (5 Weeks) | COMPLETED | Placebo | 72 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Ziprasidone | 3 | 86 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 85 | |
| other | Diarrhoea | Gastrointestinal disorders | Ziprasidone | 2 | 86 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 85 | |
| other | Nausea | Gastrointestinal disorders | Ziprasidone | 12 | 86 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 85 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | Ziprasidone | 2 | 86 | |
| other | Salivary hypersecretion | Gastrointestinal disorders | Placebo | 0 | 85 | |
| other | Vomiting | Gastrointestinal disorders | Ziprasidone | 9 | 86 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 85 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ziprasidone | 0 | 86 |
| Total, all-cause mortality | Placebo | 0 | 85 |
| Total, other adverse events | Ziprasidone | 65 | 86 |
| Total, other adverse events | Placebo | 35 | 85 |
| Total, serious adverse events | Ziprasidone | 3 | 86 |
| Total, serious adverse events | Placebo | 0 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35394365 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ziprasidone vs Placebo: Number of Participants With Physical Examination Abnormalities | Trial comparisons |
| Ziprasidone vs Placebo: Number of Participants With Laboratory Abnormalities | Trial comparisons |
| Ziprasidone vs Placebo: deaths from any cause | Trial comparisons |
| Ziprasidone vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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