NCT03573297 is a Phase 3 clinical trial of Cariprazine in Bipolar I Disorder, sponsored by AbbVie.

Who is sponsoring NCT03573297?

NCT03573297 is sponsored by AbbVie.

What drugs are being tested in NCT03573297?

Interventions in NCT03573297: Cariprazine, Placebo.

What condition does NCT03573297 study?

NCT03573297 studies Bipolar I Disorder, Mania, Depression.

Is NCT03573297 still recruiting?

NCT03573297 is currently completed. Last updated 28 September 2023.

Are results published for NCT03573297?

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

Last reviewed 2023-09-28 · How we verify

NCT03573297

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

A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

Completed Phase 3 Results posted Last updated 28 September 2023

What this trial tests

Phase 3 trial testing Cariprazine in Bipolar I Disorder in 901 participants. Completed in 5 September 2022.

Timeline

15 June 2018

Primary endpoint
5 September 2022

5 September 2022

Quick facts

Lead sponsor	AbbVie
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	901
Start date	15 June 2018
Primary completion	5 September 2022
Estimated completion	5 September 2022
Sites	108 locations across Russia, Malaysia, Ukraine, Serbia, Taiwan, Poland, South Korea, Puerto Rico

Drugs / interventions tested

Cariprazine (CARIPRAZINE) — full drug profile →
Placebo

Conditions studied

Bipolar I Disorder — all drugs for Bipolar I Disorder →
Mania — all drugs for Mania →
Depression — all drugs for Depression →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 65, any sex, with Bipolar I Disorder or Mania. 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.

Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period Primary · From Week 16 to Week 55

Relapse was defined as the occurrence of any 1 of the following: * Young Mania Rating Score (YMRS) total score ≥ 17 (range 0-60; higher score indicates a worse outcome); * Montgomery Asberg Depression Rating Scale; (MADRS) total score ≥ 20 (range 0-60; higher score indicates more depressive symptoms); * Clinical Global Impression-Improvement scale (CGI-S) ≥ 4 (range from 1 \[normal, not at all ill\] to 7 \[extremely ill\]); * Initiation of additional psychiatric medication; * Psychiatric hospitalization; * Exacerbation of illness as judged by clinical impression of the Investigator. Time to

25% percentile

Group	Value	95% CI
Double-Blind Placebo QD	NA	156.0 – NA
Double-Blind Cariprazine 1.5 mg QD	NA	220.0 – NA
Double-Blind Cariprazine 3.0 mg QD	NA	224.0 – NA

50% percentile

Group	Value	95% CI
Double-Blind Placebo QD	NA	NA – NA
Double-Blind Cariprazine 1.5 mg QD	NA	NA – NA
Double-Blind Cariprazine 3.0 mg QD	NA	NA – NA

75% percentile

Group	Value	95% CI
Double-Blind Placebo QD	NA	NA – NA
Double-Blind Cariprazine 1.5 mg QD	NA	NA – NA
Double-Blind Cariprazine 3.0 mg QD	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Open Label Treatment Period: from enrollment (all-cause mortality [ACM]) or first dose of study drug (adverse events [AEs]) through Week 16 (Day113). Double-Blind Treatment Period (ACM/AEs): From first dose of double-blind treatment up to end of study, Week 59 (Day 414).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Open Label Treatment Period

Serious: 19/896 (2%)

Deaths: 1/901

Double-Blind Placebo QD

Serious: 5/145 (3%)

Deaths: 1/145

Double-Blind Cariprazine 1.5 mg QD

Serious: 7/144 (5%)

Deaths: 0/147

Double-Blind Cariprazine 3.0 mg QD

Serious: 3/147 (2%)

Deaths: 0/148

Serious adverse events (26 terms)

Reaction	System	Open Label Treatment Period	Double-Blind Placebo QD	Double-Blind Cariprazine 1…	Double-Blind Cariprazine 3…
SUICIDAL IDEATION	Psychiatric disorders	—	—	—	—
BIPOLAR DISORDER	Psychiatric disorders	—	—	—	—
MANIA	Psychiatric disorders	—	—	—	—
BIPOLAR I DISORDER	Psychiatric disorders	—	—	—	—
PALPITATIONS	Cardiac disorders	—	—	—	—
APPENDICEAL ABSCESS	Infections and infestations	—	—	—	—
APPENDICITIS PERFORATED	Infections and infestations	—	—	—	—
CORONAVIRUS PNEUMONIA	Infections and infestations	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
GASTROENTERITIS VIRAL	Infections and infestations	—	—	—	—
SEPSIS	Infections and infestations	—	—	—	—
FALL	Injury, poisoning and procedural complications	—	—	—	—
OVERDOSE	Injury, poisoning and procedural complications	—	—	—	—
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	—	—	—	—
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	—	—	—	—
CERVIX CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
HYPOAESTHESIA	Nervous system disorders	—	—	—	—
PARAESTHESIA	Nervous system disorders	—	—	—	—
SACRAL RADICULOPATHY	Nervous system disorders	—	—	—	—
DEPRESSION	Psychiatric disorders	—	—	—	—
HALLUCINATION, AUDITORY	Psychiatric disorders	—	—	—	—
MAJOR DEPRESSION	Psychiatric disorders	—	—	—	—
SUICIDE ATTEMPT	Psychiatric disorders	—	—	—	—
ASTHMA	Respiratory, thoracic and mediastinal disorders	—	—	—	—
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Open Label Treatment Period	Double-Blind Placebo QD	Double-Blind Cariprazine 1…	Double-Blind Cariprazine 3…
AKATHISIA	Nervous system disorders	—	—	—	—
HEADACHE	Nervous system disorders	—	—	—	—
INSOMNIA	Psychiatric disorders	—	—	—	—
NAUSEA	Gastrointestinal disorders	—	—	—	—
WEIGHT INCREASED	Investigations	—	—	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—

Most-reported serious reactions: SUICIDAL IDEATION, BIPOLAR DISORDER, MANIA, BIPOLAR I DISORDER, PALPITATIONS, APPENDICEAL ABSCESS, APPENDICITIS PERFORATED, CORONAVIRUS PNEUMONIA.

Data from ClinicalTrials.gov NCT03573297 adverse events section.

Sponsor's own description

1\) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day

Publications & conference data

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

Cariprazine in the Treatment of Bipolar Disorder: Within and Beyond Clinical Trials.
Do A, Keramatian K, Schaffer A, Yatham L. · · 2021 · cited 9× · PMID 34970166 · DOI 10.3389/fpsyt.2021.769897
Cariprazine for Treating Schizophrenia, Mania, Bipolar Depression, and Unipolar Depression: A Review of Its Efficacy.
Tarzian M, Ndrio M, Kaja S, Beason E, et al · · 2023 · cited 5× · PMID 37378203 · DOI 10.7759/cureus.39309
Existing and emerging pharmacological approaches to the treatment of mania: A critical overview.
Sparacino G, Verdolini N, Vieta E, Pacchiarotti I. · · 2022 · cited 4× · PMID 35461339 · DOI 10.1038/s41398-022-01928-8
ACNP 63rd Annual Meeting: Poster Abstracts P1-P304
· 2024
Efficacy of Cariprazine in the Psychosis Spectrum: A Systematic Review and Network Meta-Analysis of Randomised Controlled Trials in Schizophrenia and Bipolar Disorder.
Tarchi L, Bugini S, Dani C, Cassioli E, et al · · 2024 · PMID 39382790 · DOI 10.1007/s40263-024-01125-9

Verify or expand the search:

Other trials of Cariprazine

Trials testing the same drug.

NCT05060549 — Dopamine D3 Receptor Occupancy in Bipolar Depression · Phase 4 · withdrawn
NCT06433635 — Sequential Multiple Assignment Randomized Trial for Bipolar Depression · Phase 4 · active not recruiting
NCT05913947 — Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) · Phase 4 · recruiting
NCT05368558 — Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Sc · Phase 3 · terminated
NCT05384483 — Cariprazine Versus Placebo for Social Anxiety Disorder · Phase 4 · completed

Other recruiting trials for Bipolar I Disorder

Currently open trials in the same condition.

NCT07213466 — Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder · Phase 4 · recruiting
NCT06433635 — Sequential Multiple Assignment Randomized Trial for Bipolar Depression · Phase 4 · active not recruiting
NCT06221852 — Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder · NA · recruiting
NCT05648591 — Safety and Tolerability of Open-Labeled Iloperidone in Adolescents · Phase 4 · recruiting
NCT05427123 — Children's Bipolar Network Treatment Trial I · recruiting

Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

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 NCT03573297 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 AbbVie
Last refreshed: 28 September 2023

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/NCT03573297.

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