This Study Aims to Compare the Efficacy and Safety of Lumateperone and Cariprazine in Patients With Bipolar I Depression Using Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression Bipolar Severity Scale (CGI-BP-S) and Recording Treatment Emergent Adverse Effects (LUCAR-BD)
Comparison Of Efficacy And Safety Of Lumateperone And Cariprazine as Adjunctive Treatment in Bipolar I Depression
This study aims to compare the efficacy and safety of lumateperone and cariprazine as adjuncts in patients with depression associated with bipolar I using standardized efficacy assessment tools such as the Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression bipolar severity scale (CGI-BP-S) and recording treatment emergent adverse effect.
Participants will undergo baseline assessment on day 0 using these scales. Follow-up assessments using MADRS and CGI scales will be conducted at Day 15, Day 30 and Day 45. Safety analysis will be performed for all participants who receive at least one dose of study medication. Vitals and treatment-emergent adverse events (TEAEs) will be recorded at every visit
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Bipolar I disorder is a chronic and recurrent psychiatric illness characterized by episodes of mania and depression that significantly impair functioning and quality of life. Bipolar depression is associated with substantial morbidity, increased risk of suicide, and reduced psychosocial functioning. Although mood stabilizers remain the cornerstone of treatment, many patients experience inadequate response to mood stabilizer monotherapy, necessitating the use of adjunctive pharmacological agents.
Cariprazine and lumateperone are newer antipsychotic agents that have demonstrated efficacy in the treatment of bipolar depression. Cariprazine is a dopamine D3/D2 receptor partial agonist with preferential affinity for D3 receptors, whereas lumateperone exhibits a unique mechanism involving modulation of dopaminergic, serotonergic, and glutamatergic neurotransmission. Despite evidence supporting the efficacy of both agents, direct comparative data regarding their effectiveness and safety as adjunctive therapy in Bipolar I depression remain limited.
This randomized controlled trial aims to compare the efficacy and safety of lumateperone and cariprazine as adjunctive therapy to ongoing mood stabilizer treatment in adults diagnosed with Bipolar I Disorder experiencing a current depressive episode. Eligible participants will be randomly assigned to receive either lumateperone or cariprazine in addition to their prescribed mood stabilizer for an 6-week treatment period.
The primary efficacy outcome will be the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to Week 6. Secondary efficacy outcomes will include changes in Clinical Global Impression for Bipolar Disorder-Severity (CGI-BP-S) depression scores and assessment of treatment response and remission rates. Treatment response will be defined as a clinically significant reduction in depressive symptoms as measured by MADRS, while remission will be determined using established MADRS threshold criteria.
Safety and tolerability will be evaluated throughout the study through regular monitoring of vital signs, physical examinations, and the occurrence of treatment-emergent adverse events (TEAEs). All adverse events will be documented and assessed for severity and relationship to study medication.
The findings of this study are expected to provide comparative evidence regarding the effectiveness and safety of lumateperone and cariprazine as adjunctive treatment options for Bipolar I depression and may assist clinicians in making evidence-based treatment decisions for patients who demonstrate an inadequate response to mood stabilizer therapy alone.
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Wardha Mazhar Malik, MBBS, Mphil
- Numéro de téléphone: 03315108703
- E-mail: wardhajibran@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patients aged 18-60 years
- Diagnosed with bipolar I depression according to DSM-5 criteria
- On stable dose of mood stabilizer (lithium or valproate) for at least 2 weeks
- Moderate to severe depressive symptoms (baseline MADRS score ≥20)
- Willing to provide informed consent
Exclusion Criteria:
• Current manic or mixed episode
- Rapid cycling bipolar disorder
- Substance use disorder
- Severe neurological illness or medical emergency
- Pregnancy or lactation
- Treatment-resistant depression requiring ECT
- Active suicidal risk requiring emergency intervention
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: lumateperone plus mood stabilizer
Lumateperone administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode
|
Lumateperone administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode
|
|
Comparateur actif: Cariprazine plus mood stabilizer
Cariprazine administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode.
|
Cariprazine administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
Délai: Baseline to Week 6 (Day 45)
|
Change in depressive symptom severity from baseline to Week 8, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score having minimum to maximum range of 0-60 in patients with Bipolar I depressive episode receiving adjunctive lumateperone or cariprazine with mood stabilizers.•
a decrease in score shows improvement.
Response to treatment (≥50% decrease in MADRS Total score from baseline to end) and remission (MADRS Total score ≤12)
|
Baseline to Week 6 (Day 45)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- WMDC-RCT-BD-2026-01
- WM&DC/R&D (IERB) /2026/264 (Autre identifiant: Institutional Ethical Review Board, Watim Medical and Dental College)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .