Trial reportInternational clinical psychopharmacology2019
Long-term safety and tolerability of cariprazine as adjunctive therapy in major depressive disorder.
Trial report in International clinical psychopharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 188 citations in OpenAlex.
- Depressive disorders: systematic review of approved psychiatric medications (2009-April 2025) and pipeline phase 3 medications.BMC psychiatry · 2025Pooled it
- Real-Life Clinical Experience With Cariprazine: A Systematic Review of Case Studies.Frontiers in psychiatry · 2022Pooled it
- The structure of the dopamine DScience advances · 2026Article
- The Serotonin 2B (5-HT2B) Receptor: A Narrative Review of Preclinical and Clinical Evidence on the Safety Considerations and Therapeutic Potential for the Treatment of Depression.Clinical pharmacology and therapeutics · 2026Review
- Managing schizophrenia with affective, sexual, metabolic and substance-use comorbidities: pharmacological considerations from an expert consensus.Annals of general psychiatry · 2025Article
- Impact of cariprazine on body weight and blood pressure among adults with bipolar I disorder, schizophrenia, or major depressive disorder in a real-world setting.Annals of general psychiatry · 2025Article
- Exploring cariprazine as a treatment option for varied depression symptom clusters.Frontiers in psychiatry · 2024Review
- An "Awakener" Patient Suffering From Treatment-Resistant Depression Following Adjunctive Cariprazine.Cureus · 2024Article
- Cariprazine for Treating Schizophrenia, Mania, Bipolar Depression, and Unipolar Depression: A Review of Its Efficacy.Cureus · 2023Review
- Switching Clozapine to Cariprazine in Three Patients with Persistent Symptoms of Schizophrenia: A Case Series.Neuropsychiatric disease and treatment · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Lack of treatment response is a critical problem in major depressive disorder (MDD). Cariprazine is a D3-preferring dopamine D3/D2 receptor partial agonist and 5-HT1A partial agonist. This phase 3, multicenter, open-label, long-term (26-week), flexible-dose (1.5-4.5 mg/day) study assessed the long-term safety and tolerability of cariprazine used adjunctively with antidepressant therapy in adult patients with MDD who had either completed a lead-in study (n=311) or had been newly recruited (n=131). A higher percentage of continuing patients (66.2%) than new patients (35.9%) completed the study. The most common reason for discontinuation was adverse events (AEs; 13.9%); 79% of patients experienced a treatment-emergent AE [most common: akathisia (15.9%,) headache (11.6%)]. Serious AEs occurred in 2% of patients; two deaths occurred (one traffic accident, one completed suicide, both considered unrelated to treatment). The mean changes in clinical laboratory, cardiovascular, and ophthalmologic parameters were generally not clinically relevant. The mean (SD) changes from the open-label baseline in Montgomery-Åsberg Depression Rating Scale total score and Clinical Global Impression-Severity score at week 26 were -7.3 (9.5) and -1.0 (1.2), respectively. By week 26, 53.3% of patients were in remission (Montgomery-Åsberg Depression Rating Scale total score≤10). The results suggest that cariprazine was generally safe and well tolerated as adjunctive therapy to treat MDD.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.