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2013-002055-15: CONTROLLED MULTICENTER STUDY ON THE MOOD-STABILIZING EFFECT OF MEMANTINE IN BIPOLAR I DISORDERS STUDIO MULTICENTRICO CONTROLLATO SULL'EFFETTO PROFILATTICO DELLA MEMANTINA NEL DISTURBO BIPOLARE DI TIPO I |
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| Ongoing | 3 | 106 | Europe | Coated tablet, EBIXA, LAMOTRIGINE DOC -GENERIC | UNIVERSITY OF SASSARI, UNIVERSITY OF SASSARI | BIPOLAR I MOOD DISORDERS DISTURBO DELL'UMORE DI TIPO I, MANIC-DEPRESSIVE ILLNESS MALATTIA MANIACO-DEPRESSIVA, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
| Ongoing | 3 | 60 | Europe | Pioglitazona, A10BG03, Tablet | Hospital Universitario Araba (Sede Santiago), No | Bipolar disorder Trastorno bipolar, Bipolar disorder Trastorno bipolar, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
2004-000687-27: A 52 week open-label extension study to evaluate the safety and tolerability of licarbazepine 750-2500 mg/d in the treatment of manic episodes of bipolar I disorder |
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| | 3 | 16 | Europe | Licarbazepine, LIC477D, | Novartis Pharma AG | Bipolar I disorder, manic and mixed episodesDSM-IV criteria 296.0, 296.4 or 296.6 | | | | |
2009-011253-40: Paroxetine or Quetiapine in Addition to Mood Stabilizers in Bipolar Depression |
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| Ongoing | 3 | 40 | Europe | DAPAROX*28CPR RIV 20MG PVC/PE/, SEROQUEL*60CPR RIV 100MG, DAPAROX*28CPR RIV 20MG PVC/PE/, SEROQUEL*60CPR RIV 100MG | AZIENDA SANITARIA OSPEDALIERA \"S. GIOVANNI BATTISTA DI TORINO\" | Major Depressive Episode in Bipolar Disorder | | | | |
2018-003313-17: Efficacy of vitamin D supplementation in patients with depressive disorder or bipolar disorder: randomized controlled clinical trial Efficacia della supplementazione con vitamina d in pazienti con disturbo depressivo o disturbo bipolare: studio clinico controllato randomizzato |
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| Not yet recruiting | 3 | 150 | Europe | DIBASE, [DIBASE], Oral drops, solution, DIBASE - "50.000 U.I./2,5 ML SOLUZIONE ORALE" 1 CONTENITORE MONODOSE DA 2,5 ML | AZIENDA OSPEDALIERA UNIVERSITARIA SENESE, Abiogen | patients with major depressive disorder or bipolar disorder pazienti affetti da disturbo depressivo maggiore o disturbo bipolare, patients with major depressive disorder or bipolar disorder pazienti affetti da disturbo depressivo maggiore o disturbo bipolare, Psychiatry and Psychology [F] - Behaviours [F01] | | | | |
| Ongoing | 3 | 290 | Europe | Pramipexole 0.18mg Tablets, Pramipexol Aurobindo 0.18 mg, Pramipexole Aurobindo 0.18 mg, Pramipexole 0.7mg Tablets, Pramipexol Aurobindo 0.7 mg, Pramipexole Aurobindo 0.7 mg, Tablet, Pramipexole 0.18mg Tablets, Pramipexol Aurobindo 0.18 mg, Pramipexole Aurobindo 0.18 mg, Pramipexole 0.7mg Tablets, Pramipexol Aurobindo 0.7 mg, Pramipexole Aurobindo 0.7 mg | Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, NIHR HTA programme | Bipolar disorder (BD), A mental disorder that causes periods of depression and periods of abnormally elevated mood., Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
2019-002213-19: A randomised study to evaluate Lurasidone versus Placebo in improving cognitive functioning in patients with Bipolar Disorder |
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| Ongoing | 3 | 300 | Europe | Latuda, n/a, Film-coated tablet, Latuda | University of British Columbia, University of British Columbia | Euthymic Bipolar disorder, Bipolar Disorder, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
2018-002749-12: Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression |
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| Not yet recruiting | 3 | 514 | Europe | ITI-007, Capsule | Intra-Cellular Therapies, Inc. (ITI), Intra-Cellular Therapies, Inc. (ITI) | Major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression), Bipolar Depression, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
2019-002778-30: Double-blind, randomised, multicenter study to evaluate the efficacy and safety of memantine in adolescents with Bipolar Disorder Studio multicentrico randomizzato in doppio cieco per valutare l'efficacia e la sicurezza della memantina negli adolescenti con Disturbo Bipolare |
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| Not yet recruiting | 3 | 68 | Europe | MEMANTINA ACCORD, [NA], Film-coated tablet, MEMANTINA ACCORD - 10 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PE/PVDC/ALLUMINIO) - 56 COMPRESSE | IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA, Ministero della Salute | Bipolar Disorder Disturbo Bipolare, Bipolar Disorder in adolescents Disturbo bipolare negli adolescenti, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
SevereBD, NCT03396601: NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression |
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| Active, not recruiting | 3 | 150 | US | Ketamine Hydrochloride, Placebo | NeuroRx, Inc., Target Health Inc. | Bipolar Depression, Suicidal Ideation | 12/24 | 12/24 | | |
NCT04819776: Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder |
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| Completed | 3 | 417 | Europe, US | Iloperidone, FANAPT®, VYV-683, Iloperidone Placebo | Vanda Pharmaceuticals | Bipolar I Disorder | 09/22 | 08/23 | | |
NCT02800161: Trehalose as add-on Therapy in Bipolar Depression |
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| Completed | 3 | 60 | Europe | Trehalose, Maltose | Consorcio Centro de Investigación Biomédica en Red, M.P., Stanley Medical Research Institute | Bipolar Disorder, Bipolar Depression | 10/22 | 10/22 | | |
NCT04285515 / 2019-004440-29: Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder |
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| Completed | 3 | 488 | Europe, US, RoW | Lumateperone, Placebos | Intra-Cellular Therapies, Inc. | Bipolar Depression, Major Depressive Disorder | 11/22 | 11/22 | | |
NCT02918370: Aripiprazole for Bipolar Disorder and Alcohol Use Disorder |
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| Completed | 3 | 132 | US | Aripiprazole, Abilify, Placebo, Sugar Pill | University of Texas Southwestern Medical Center | Bipolar Disorder, Alcoholism, Alcohol Abuse | 06/23 | 06/23 | | |
SBD-ASIB, NCT03396068: NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation |
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| Active, not recruiting | 3 | 72 | US | NRX-101, Cyclurad, Lurasidone HCl | NeuroRx, Inc., Target Health Inc. | Bipolar Depression, Suicidal Ideation | 12/24 | 12/24 | | |
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NCT04315792: Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients |
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| Recruiting | 3 | 124 | US | Endoxifen, Placebo oral tablet | Jina Pharmaceuticals Inc., Novum Pharmaceutical Research Services, Lambda Therapeutic Research Ltd., Intas Pharmaceuticals, Ltd. | Bipolar I Disorder | 07/23 | 05/24 | | |
2020-000405-83: A clinical study to evaluate iloperidone in the treatment of patients with acute manic episodes associated with Bipolar I Disorder Badanie kliniczne oceniające stosowanie iloperidonu w leczeniu pacjentów z ostrymi epizodami manii związanymi z chorobą dwubiegunową typu I |
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| Not yet recruiting | 3 | 400 | Europe, RoW | Iloperidone, VYV-683, Capsule, Tablet | Vanda Pharmaceuticals Inc., Vanda Pharmaceuticals Inc. | Acute manic episodes associated with Bipolar I Disorder Ostre epizody manii związane z chorobą dwubiegunową typu I, Bipolar I Disorder Choroba dwubiegunowa typu I, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
| Completed | 3 | 524 | Europe, US, RoW | ALKS 3831 | Alkermes, Inc. | Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder | 09/23 | 09/23 | | |
| Recruiting | 3 | 150 | Europe, Canada, Japan, US | lurasidone, Latuda, Placebo | Nazlin Walji | Bipolar Disorder | 12/24 | 03/25 | | |
NCT06229210: Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or Bipolar Disorder |
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| Recruiting | 3 | 500 | US | Lumateperone | Intra-Cellular Therapies, Inc. | Schizophrenia, Bipolar Disorder | 12/27 | 12/27 | | |
NCT06372964: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients |
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| Recruiting | 3 | 384 | US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Bipolar Depression | 04/27 | 05/27 | | |
NCT05803642: A Study of Olanzapine in Patients With Acute Agitation |
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| Not yet recruiting | 3 | 318 | NA | Olanzapine, Haloperidol | Qilu Pharmaceutical Co., Ltd. | Acute Agitation | 05/24 | 07/24 | | |
| Recruiting | 3 | 104 | Europe | Ketamine, Ketalar, Midazolam, Hypnovel | University of Dublin, Trinity College | Major Depressive Episode, Unipolar Depression, Bipolar Depression | 06/24 | 12/24 | | |
NCT06462586: Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania |
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| Recruiting | 3 | 350 | US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Bipolar Disorder, Manic | 03/26 | 04/26 | | |
NCT06462612: Study of Lumateperone in the Treatment of Patients With Bipolar Mania |
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| Not yet recruiting | 3 | 350 | US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Bipolar Disorder, Manic | 05/26 | 06/26 | | |
APOLLO, NCT03423680: A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression |
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| Recruiting | 3 | 390 | RoW | Abilify 2, 5, 10, 15mg (Tablet), Placebo of Abilify 2, 5, 10, 15mg (Tablet) | Korea Otsuka Pharmaceutical Co., Ltd. | Depression, Bipolar | 10/24 | 11/24 | | |
NCT05625555: Predictors of Intravenous Ketamine Response in TRD |
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| Recruiting | 3 | 40 | Canada | Ketamine, Ketamine Hydrochloride, Kevlar, Midazolam, Midazolam Hydrochloride | Abraham Nunes, Nova Scotia Health Authority | Treatment Resistant Depression, Major Depressive Disorder, Bipolar Disorder | 01/25 | 02/25 | | |
NCT04777357: A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. |
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| Recruiting | 3 | 380 | US, RoW | Cariprazine, Vraylar, Placebo | AbbVie | Depression, Bipolar I Disorder | 03/27 | 03/27 | | |
NCT04569448: Brexpiprazole Treatment for Bipolar I Depression |
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| Recruiting | 3 | 58 | Canada | Brexpiprazole | Douglas Mental Health University Institute, McMaster University, Jewish General Hospital | Bipolar Depression | 02/25 | 02/25 | | |
NCT05658510: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) |
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| Active, not recruiting | 3 | 450 | US | BXCL501, Dexmedetomidine, Matching Placebo, Placebo | BioXcel Therapeutics Inc, Worldwide Clinical Trials | Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders | 03/25 | 03/25 | | |
NCT05169710 / 2021-002126-24: A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder. |
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| Terminated | 3 | 83 | Europe, Canada, Japan, US | SEP-4199 CR 200 mg, SEP-4199 CR 400 mg, Placebo | Sumitomo Pharma America, Inc., Sunovion Pharmaceuticals Inc. | Depressive Episodes, Bipolar I Depression | 10/23 | 10/23 | | |
NCT04578756: Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder |
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| Recruiting | 3 | 280 | US | Cariprazine Flexible Dose | AbbVie | Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD) | 09/25 | 09/25 | | |
| Recruiting | 3 | 30 | Canada | Cariprazine, VRAYLAR®, Placebo | Jayasree Basivireddy | Bipolar I Disorder, Cognitive Impairment | 09/25 | 09/26 | | |
NCT03674671: Ketamine Versus Electroconvulsive Therapy in Depression |
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| Suspended | 3 | 240 | Canada | Intravenous Ketamine, Ketalar, Electroconvulsive Therapy, ECT | University of Ottawa, McGill University, Queen's University, University Health Network, Toronto, Ontario Shores Centre for Mental Health Sciences | Depressive Disorder, Major, Bipolar Depression | 12/25 | 12/25 | | |
INTENSIFY BD, NCT05973786: The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. |
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| Recruiting | 3 | 418 | Europe | Escitalopram, ATC code: N06AB10, Sertraline, ATC code: N06AB06, Venlafaxine, ATC code: N06AX16, Lithium, ATC code: N05AN01, Valproate acid, ATC code: N03AG01, Quetiapine, ATC code: N05AH04 | Dr. Inge Winter, Universität Münster | Bipolar Depression | 06/26 | 06/26 | | |
INTENSIFY, NCT05603104: Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure |
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| Not yet recruiting | 3 | 1254 | RoW | Clozapine, ATC code: N05AH02, Esketamine Nasal Product, ATC code: N06AB10, Escitalopram, Sertraline, ATC code: N06AB06, Venlafaxine, ATC code: N06AX16, Lithium, ATC code: N05AN01, Valproate acid, ATC code: N03AG01, Quetiapine, ATC code: N05AH04, Second-line Antidepressants, Second-line Antipsychotics, Ketamine Hydrochloride, N01AX03, Esketamine hydrochloride, N015X14 | Dr. Inge Winter, Universität Münster | Schizophrenia and Related Disorders, Major Depressive Disorder, Bipolar Depression | 06/26 | 06/26 | | |
NCT05303064: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder |
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| Recruiting | 3 | 220 | US, RoW | OLZ/SAM, ALKS 3831, LYBALVI, Olanzapine | Alkermes, Inc. | Schizophrenia, Bipolar I Disorder | 09/26 | 09/26 | | |
NCT04987229: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects |
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| Enrolling by invitation | 3 | 236 | US, RoW | OLZ/SAM, ALKS 3831 | Alkermes, Inc. | Bipolar I Disorder, Schizophrenia | 09/27 | 09/27 | | |
NCT05227209 / 2021-002108-11: A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression). |
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| Terminated | 3 | 64 | Europe, Japan, US | SEP-4199 CR | Sumitomo Pharma America, Inc., Sunovian Pharmaceuticals Inc. | Depressive Episodes, Bipolar I Depression | 11/23 | 11/23 | | |
| Recruiting | 3 | 360 | Canada | Cannabidiol, CBD, Placebo | University of British Columbia | Bipolar Disorder | 12/29 | 12/30 | | |
ACTRN12620000703909p: The Candesartan Adjunctive Bipolar Depression Trial - CADET: A double-blind, randomised, placebo-controlled trial
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| Not yet recruiting | 2/3 | 240 | | | Deakin University , Medical Research Future Fund (MRFF) National Health and Medical Research Council (NHMRC) | Bipolar depression | | | | |
ACTRN12620000703909: The Candesartan Adjunctive Bipolar Depression Trial - CADET: A double-blind, randomised, placebo-controlled trial
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| Recruiting | 2/3 | 240 | | | Deakin University , Medical Research Future Fund (MRFF) National Health and Medical Research Council (NHMRC) | Bipolar depression | | | | |
NCT04035798: add-on Low Dose Memantine in Middle-to-old Aged Bipolar II Disorder Patients |
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| Recruiting | 2/3 | 120 | RoW | Memantine or placebo | National Cheng-Kung University Hospital, Ministry of Science and Technology, Taiwan | Bipolar II Disorder | 07/21 | 07/22 | | |
NCT03279224: Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Bipolar Disorder |
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| Active, not recruiting | 2/3 | 35 | Canada | Allogenic FMT, Autologous FMT | Valerie Taylor, University Health Network, Toronto | Bipolar Depression | 03/22 | 12/22 | | |
| Completed | 2/3 | 74 | US | NRX-101, Lurasidone HCl, Latuda | NeuroRx, Inc., Prevail Infoworks, Inc | Bipolar Depression, Suicidal Ideation and Behavior | 02/24 | 03/24 | | |
| Recruiting | 2/3 | 256 | US | BHV-7000, Placebo | Biohaven Therapeutics Ltd. | Bipolar Disorder | 03/25 | 04/25 | | |
| Recruiting | 2/3 | 100 | RoW | Magnetic Seizure Therapy, MST, Electroconvulsive Therapy, ECT | University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo | Major Depressive Disorder, Bipolar Depression | 06/24 | 06/25 | | |
