NCT03768726 is a Phase 3 clinical trial of Ziprasidone in Bipolar Disorder, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Who is sponsoring NCT03768726?

NCT03768726 is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

What drugs are being tested in NCT03768726?

Interventions in NCT03768726: Ziprasidone, Placebo.

What condition does NCT03768726 study?

NCT03768726 studies Bipolar Disorder.

Is NCT03768726 still recruiting?

NCT03768726 is currently terminated. Last updated 16 June 2021.

Are results published for NCT03768726?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-16 · How we verify

NCT03768726

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder

Terminated Phase 3 Results posted Last updated 16 June 2021

What this trial tests

Phase 3 trial testing Ziprasidone in Bipolar Disorder in 23 participants. Terminated before completion.

Timeline

21 December 2018

Primary endpoint
31 July 2020

31 July 2020

Quick facts

Lead sponsor	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	21 December 2018
Primary completion	31 July 2020
Estimated completion	31 July 2020
Sites	9 locations across United States

Drugs / interventions tested

Ziprasidone (ziprasidone) — full drug profile →
Placebo

Conditions studied

Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full company profile →

Who can join

Adults 10 to 17, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks)

An adverse event (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.

AEs

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	7
Placebo in A1281198 Then Ziprasidone in A1281201	12

SAEs

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0
Placebo in A1281198 Then Ziprasidone in A1281201	1

Number of Participants With Laboratory Abnormalities Secondary · A1281201: Day 1 up to 1 Week after last dose of study medication (maximum up to 27 Weeks)

Hemoglobin (Hg), hematocrit, erythrocytes: \<0.8\*lower limits of normal (LLN); platelets: \<0.5\*LLN\>1.75\*upper limits of normal (ULN); leukocytes (leu), glucose-fasting:\<0.6\*LLN\>1.5\*ULN; lymphocytes (lym), lym/leu, neutrophils (neu), neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: \<0.8\*LLN\>1.2\*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: \>1.2\*ULN; bilirubin (total, direct, indirect):\>1.5\*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:\>3.0\*ULN; blood urea nit

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	5
Placebo in A1281198 Then Ziprasidone in A1281201	11

Number of Participants With Physical Examination Abnormalities at Baseline and Week 26 Secondary · Baseline (last measurement from A1281198), Week 26 of A1281201

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.

Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0
Placebo in A1281198 Then Ziprasidone in A1281201	0

Week 26

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0
Placebo in A1281198 Then Ziprasidone in A1281201	0

Change From Baseline in Blood Pressure at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Secondary · Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in sitting and standing systolic and diastolic blood pressure in millimeter of mercury (mmHg) was reported.

Sitting Systolic Blood Pressure, Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	111.70	± 13.712
Placebo in A1281198 Then Ziprasidone in A1281201	111.38	± 11.384

Sitting Systolic Blood Pressure, Change at Week 1

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	2.44	± 10.944
Placebo in A1281198 Then Ziprasidone in A1281201	-1.00	± 11.505

Sitting Systolic Blood Pressure, Change at Week 2

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.43	± 6.024
Placebo in A1281198 Then Ziprasidone in A1281201	0.08	± 10.431

Sitting Systolic Blood Pressure, Change at Week 4

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	3.29	± 8.036
Placebo in A1281198 Then Ziprasidone in A1281201	-1.83	± 8.321

Sitting Systolic Blood Pressure, Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	3.17	± 6.969
Placebo in A1281198 Then Ziprasidone in A1281201	-3.45	± 11.903

Sitting Systolic Blood Pressure, Change at Week 10

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-0.80	± 9.203
Placebo in A1281198 Then Ziprasidone in A1281201	-3.09	± 11.674

Sitting Systolic Blood Pressure, Change at Week 14

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-2.80	± 9.011
Placebo in A1281198 Then Ziprasidone in A1281201	-7.09	± 8.949

Sitting Systolic Blood Pressure, Change at Week 18

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-2.67	± 8.327
Placebo in A1281198 Then Ziprasidone in A1281201	-0.82	± 10.852

Change From Baseline in Pulse Rate at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Secondary · Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline pulse rate in beats per minute was reported in sitting and standing positions.

Sitting, Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	77.90	± 9.678
Placebo in A1281198 Then Ziprasidone in A1281201	73.38	± 11.701

Sitting, Change at Week 1

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.78	± 8.969
Placebo in A1281198 Then Ziprasidone in A1281201	2.00	± 9.254

Sitting, Change at Week 2

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.00	± 6.758
Placebo in A1281198 Then Ziprasidone in A1281201	8.08	± 11.782

Sitting, Change at Week 4

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-3.29	± 7.365
Placebo in A1281198 Then Ziprasidone in A1281201	2.00	± 9.789

Sitting, Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-1.17	± 7.139
Placebo in A1281198 Then Ziprasidone in A1281201	2.00	± 10.954

Sitting, Change at Week 10

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	3.40	± 11.261
Placebo in A1281198 Then Ziprasidone in A1281201	0.18	± 14.098

Sitting, Change at Week 14

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-3.00	± 14.799
Placebo in A1281198 Then Ziprasidone in A1281201	-0.91	± 13.308

Sitting, Change at Week 18

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-0.33	± 8.622
Placebo in A1281198 Then Ziprasidone in A1281201	1.09	± 10.606

Change From Baseline in Height and Waist Circumference at Week 6, 26 and Follow-up Visit Secondary · Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in height and waist circumference in centimeter (cm) was reported.

Height, Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	159.82	± 10.182
Placebo in A1281198 Then Ziprasidone in A1281201	161.69	± 11.996

Height, Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.27	± 0.455
Placebo in A1281198 Then Ziprasidone in A1281201	0.77	± 0.984

Height, Change at Week 26

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	2.04	± 1.938
Placebo in A1281198 Then Ziprasidone in A1281201	0.55	± 1.535

Height, Change at Follow-up Visit

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.90	± 1.562
Placebo in A1281198 Then Ziprasidone in A1281201	2.42	± 1.413

Waist Circumference, Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	78.89	± 11.278
Placebo in A1281198 Then Ziprasidone in A1281201	80.23	± 13.981

Waist Circumference, Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-0.94	± 2.483
Placebo in A1281198 Then Ziprasidone in A1281201	2.23	± 7.527

Waist Circumference, Change at Week 26

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-1.02	± 2.278
Placebo in A1281198 Then Ziprasidone in A1281201	1.29	± 4.210

Waist Circumference, Change at Follow-up Visit

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-6.40	± 13.777
Placebo in A1281198 Then Ziprasidone in A1281201	2.01	± 3.778

Change From Baseline in Body Weight at Week 6, 26 and Follow-up Visit Secondary · Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in body weight in kilogram (kg) was reported.

Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	57.76	± 17.634
Placebo in A1281198 Then Ziprasidone in A1281201	62.40	± 19.375

Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.82	± 1.343
Placebo in A1281198 Then Ziprasidone in A1281201	0.78	± 2.530

Change at Week 26

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	1.62	± 2.528
Placebo in A1281198 Then Ziprasidone in A1281201	2.33	± 4.431

Change at Follow-up Visit

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	1.47	± 1.629
Placebo in A1281198 Then Ziprasidone in A1281201	4.68	± 2.639

Change From Baseline in Body Mass Index (BMI) at Week 6, 26 and Follow-up Visit Secondary · Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in BMI in kilogram per meter square (kg/m\^2) was reported.

Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	22.31	± 5.081
Placebo in A1281198 Then Ziprasidone in A1281201	23.37	± 4.709

Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.38	± 0.519
Placebo in A1281198 Then Ziprasidone in A1281201	0.91	± 2.234

Change at Week 26

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.19	± 0.954
Placebo in A1281198 Then Ziprasidone in A1281201	0.78	± 1.800

Change at Follow-up Visit

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.35	± 0.589
Placebo in A1281198 Then Ziprasidone in A1281201	1.54	± 1.447

Change From Baseline in Body Mass Index (BMI) Z-score at Week 6, 26 and Follow-up Visit Secondary · Baseline (last measurement from A1281198), A1281201: Week 6, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

BMI z-score was reported using the Children's Hospital of Philadelphia z-score calculator. Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI.

Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.58	± 1.187
Placebo in A1281198 Then Ziprasidone in A1281201	1.06	± 0.852

Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.12	± 0.122
Placebo in A1281198 Then Ziprasidone in A1281201	-0.02	± 0.511

Change at Week 26

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.21	± 0.747
Placebo in A1281198 Then Ziprasidone in A1281201	0.11	± 0.506

Change at Follow-up Visit

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.01	± 0.207
Placebo in A1281198 Then Ziprasidone in A1281201	0.26	± 0.330

Change From Baseline in Heart Rate at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Secondary · Baseline of A1281198, Day 1 (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 14, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in heart rate in beats per minute was reported.

Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	77.8	± 9.19
Placebo in A1281198 Then Ziprasidone in A1281201	71.5	± 14.12

Change at Day 1

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-4.0	± 9.40
Placebo in A1281198 Then Ziprasidone in A1281201	-1.2	± 9.09

Change at Week 1

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-2.0	± 19.24
Placebo in A1281198 Then Ziprasidone in A1281201	0.4	± 16.12

Change at Week 2

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	7.4	± 16.69
Placebo in A1281198 Then Ziprasidone in A1281201	5.0	± 16.28

Change at Week 4

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-7.3	± 8.08
Placebo in A1281198 Then Ziprasidone in A1281201	0.4	± 13.20

Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-5.0	± 13.04
Placebo in A1281198 Then Ziprasidone in A1281201	-3.9	± 14.49

Change at Week 14

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-0.6	± 15.22
Placebo in A1281198 Then Ziprasidone in A1281201	-2.6	± 15.23

Change at Week 22

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-5.0	± 0.00
Placebo in A1281198 Then Ziprasidone in A1281201	0.3	± 16.99

Change From Baseline in Electrocardiogram (ECG) Parameters at Day 1, Week 1, 2, 4, 6, 14, 22, 26 and Follow-up Visit Secondary · Baseline of A1281198, Day 1 (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 14, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

Change from baseline in PR interval, QT interval corrected using the Bazett's correction (QTcB), QT interval corrected using the Fridericia's formula (QTcF), QT interval, RR interval, QRS duration in millisecond (msec) was reported.

PR interval, Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	145.3	± 14.77
Placebo in A1281198 Then Ziprasidone in A1281201	148.5	± 14.47

PR interval, Change at Day 1

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	1.0	± 9.07
Placebo in A1281198 Then Ziprasidone in A1281201	0.4	± 10.25

PR interval, Change at Week 1

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	3.6	± 14.17
Placebo in A1281198 Then Ziprasidone in A1281201	-2.6	± 9.17

PR interval, Change at Week 2

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-4.6	± 9.22
Placebo in A1281198 Then Ziprasidone in A1281201	2.3	± 11.69

PR interval, Change at Week 4

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	3.0	± 5.16
Placebo in A1281198 Then Ziprasidone in A1281201	1.1	± 10.17

PR interval, Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.0	± 12.60
Placebo in A1281198 Then Ziprasidone in A1281201	4.0	± 10.89

PR interval, Change at Week 14

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-6.8	± 4.87
Placebo in A1281198 Then Ziprasidone in A1281201	-2.0	± 9.42

PR interval, Change at Week 22

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	12.5	± 17.68
Placebo in A1281198 Then Ziprasidone in A1281201	1.7	± 9.25

Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Week 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up Visit Secondary · Baseline (last measurement from A1281198), A1281201: Week 1, 2, 4, 6, 10, 14, 18, 22, 26, and Follow-up Visit (1 Week from last dose of study medication, anytime maximum up to Week 27)

SARS: 10-item clinician rated instrument to assess parkinsonian symptoms and related extrapyramidal side effects. All 10 items were anchored on a 5-point scale: range 0 (absence of condition, normal) to 4 (the most extreme form of condition). Total score is sum of individual item scores, ranged from 0 (normal) to 40 (most extreme symptoms and effects); higher score indicates more affected. Rows with only non-zero data/values for change in SARS total score at specified time points, for at least 1 reporting arm, are reported below.

Baseline

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.4	± 1.26
Placebo in A1281198 Then Ziprasidone in A1281201	0.0	± 0.00

Change at Week 1

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-0.2	± 0.67
Placebo in A1281198 Then Ziprasidone in A1281201	0.0	± 0.00

Change at Week 2

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.0	± 0.00
Placebo in A1281198 Then Ziprasidone in A1281201	0.2	± 0.39

Change at Week 4

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.0	± 0.00
Placebo in A1281198 Then Ziprasidone in A1281201	0.2	± 0.58

Change at Week 6

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	0.0	± 0.00
Placebo in A1281198 Then Ziprasidone in A1281201	0.2	± 0.40

Change at Week 26

Group	Value	95% CI
Ziprasidone in A1281198 and A1281201	-0.5	± 1.41
Placebo in A1281198 Then Ziprasidone in A1281201	0.0	± 0.00

Adverse events — posted to ClinicalTrials.gov

Time frame: A1281201: Day 1 up to 35 days after last dose of study medication (maximum up to 31 Weeks). Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ziprasidone in A1281198 and A1281201

Serious: 0/10 (0%)

Deaths: 0/10

Placebo in A1281198 Then Ziprasidone in A1281201

Serious: 1/13 (8%)

Deaths: 0/13

Serious adverse events (2 terms)

Reaction	System	Ziprasidone in A1281198 an…	Placebo in A1281198 Then Z…
Aggression	Psychiatric disorders	—	—
Suicidal ideation	Psychiatric disorders	—	—

Other adverse events (33 terms — click to expand)

Reaction	System	Ziprasidone in A1281198 an…	Placebo in A1281198 Then Z…
Fatigue	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Somnolence	Nervous system disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Feeling abnormal	General disorders	—	—
Pain	General disorders	—	—
Helicobacter infection	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—
Pharyngitis streptococcal	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Ligament injury	Injury, poisoning and procedural complications	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—
Blood insulin increased	Investigations	—	—
Streptococcus test positive	Investigations	—	—
Weight decreased	Investigations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—
Akathisia	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Dystonia	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Lethargy	Nervous system disorders	—	—
Memory impairment	Nervous system disorders	—	—
Sedation	Nervous system disorders	—	—
Hallucination, auditory	Psychiatric disorders	—	—
Insomnia	Psychiatric disorders	—	—
Dysmenorrhoea	Reproductive system and breast disorders	—	—
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Aggression, Suicidal ideation.

Data from ClinicalTrials.gov NCT03768726 adverse events section.

Sponsor's own description

This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents with Bipolar I Disorder (current or most recent episode manic).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy, Safety, and Tolerability of Flexibly Dosed Ziprasidone in Children and Adolescents with Mania in Bipolar I Disorder: A Randomized Placebo-Controlled Replication Study.
Findling RL, Atkinson S, Bachinsky M, Raiter Y, et al · · 2022 · cited 4× · PMID 35394365 · DOI 10.1089/cap.2021.0121
26-Week Open-Label Extension Study Evaluating the Safety and Tolerability of Flexible Doses of Oral Ziprasidone in Children and Adolescents with Bipolar I Disorder (Most Recent Episode Manic).
Atkinson S, Bachinsky M, Raiter Y, Abreu P, et al · · 2022 · PMID 36282771 · DOI 10.1089/cap.2022.0030

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03768726 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last refreshed: 16 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03768726.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03768726

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (2 terms)

Sponsor's own description

Publications & conference data

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Verify against primary sources