30 completed, 2 terminated, 1 unknown, 1 withdrawn. 34 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 34 | Completed 30, Terminated 2, Unknown 1, Withdrawn 1 |
Follow Mania: new trials by email Literature Review of Mania trials Research Report on Mania
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old Latuda (Lurasidone) - Mania, Bipolar I | Phase 4 | Withdrawn | Massachusetts General Hospital | 2017-01-01 | 2018-07-20 | |
| Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders Open-label Treatment with N-Acetylcysteine - Bipolar Disorder | Phase 4 | Completed | Massachusetts General Hospital | 40 | 2014-01-01 | 2019-11-04 |
| Inositol and Omega-3 Fatty Acids in Pediatric Mania Omega-3, Inositol - Pediatric Bipolar Spectrum Disorders | Phase 4 | Completed | Massachusetts General Hospital | 69 | 2012-02-03 | 2020-08-13 |
| An Extended-Release Form of Clonidine as an Anti-Manic Agent: An Add-on, Open-Label Study extended-release clonidine - Bipolar Disorder, Mania | Phase 4 | Terminated | Mclean Hospital | 5 | 2012-01-01 | 2017-04-26 |
| Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI Selective Serotonin Reuptake Inhibitor (SSRI) - Bipolar Disorder, Major Depression | Phase 4 | Completed | The Cleveland Clinic | 192 | 2011-11-01 | 2019-12-02 |
| Treatment of Alcohol Dependence and Comorbid Bipolar Disorder Lamotrigine, Placebo - Alcohol Dependence, Bipolar Disorder | Phase 4 | Completed | Medical University of South Carolina | 43 | 2010-02-01 | 2019-01-09 |
| Study in Adolescents With Schizophrenia or Bipolar Disorder Olanzapine, Standard behavioral weight intervention, Intense behavioral weight intervention - Bipolar I Disorder, Schizophrenia | Phase 4 | Completed | Eli Lilly and Company | 203 | 2009-09-01 | 2014-12-17 |
| Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania Utapine, Seroquel - Bipolar, Mania, Utapine | Phase 4 | Unknown | Taichung Veterans General Hospital | 40 | 2009-07-01 | 2010-01-15 |
| Prevention of Relapse & Recurrence of Bipolar Depression Lithium / Fluoxetine, Lithium / Placebo - Bipolar Disorder | Phase 4 | Completed | University of Pennsylvania | 177 | 2009-07-01 | 2020-10-19 |
| Adult Bipolar Mania Quetiapine fumarate XR, Lithium, Placebo - Acute Mania | Phase 4 | Completed | AstraZeneca | 356 | 2009-06-01 | 2012-04-19 |
| Allopurinol Maintenance Study for Bipolar Disorder Allopurinol - Bipolar Disorder, Mania | Phase 4 | Terminated | Cedars-Sinai Medical Center | 15 | 2008-08-01 | 2019-10-02 |
| Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder. Quetiapine 600mg - Bipolar Disorder, Bipolar Affective Psychosis | Phase 4 | Completed | AstraZeneca | 88 | 2008-05-01 | 2012-07-17 |
| Antidepressant Therapy in Treating Bipolar Type II Major Depression Venlafaxine, Lithium Carbonate - Bipolar Disorder, Depression | Phase 4 | Completed | University of Pennsylvania | 140 | 2007-12-01 | 2017-04-25 |
| Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder? Risperdal (risperidone) Consta, Treatment as usual - Bipolar Disorder | Phase 4 | Completed | Vanderbilt University | 50 | 2007-11-01 | 2017-07-31 |
| Allopurinol Add-on Treatment for Refractory Mania Allopurinol, Placebo - Bipolar Disorder, Mixed Mania | Phase 4 | Completed | Cedars-Sinai Medical Center | 40 | 2007-09-01 | 2019-05-08 |
| FMRI Study of Brain Response Before and After Lithium Treatment in People With Bipolar Disorder Lithium - Bipolar Disorder | Phase 4 | Completed | Indiana University | 46 | 2007-08-01 | 2016-10-17 |
| Acamprosate vs. Placebo in Bipolar Alcoholics Acamprosate, Placebo - Alcohol Dependence, Bipolar Disorder | Phase 4 | Completed | Medical University of South Carolina | 33 | 2007-04-01 | 2018-12-14 |
| Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder quetiapine SR, quetiapine sr placebo - Bipolar Disorder | Phase 4 | Completed | The University of Texas Health Science Center at San Antonio | 28 | 2007-04-01 | 2017-03-23 |
| Quetiapine for Bipolar Disorder and Alcohol Dependence Placebo, Quetiapine - Bipolar Disorder, Alcohol Dependence | Phase 4 | Completed | University of Texas Southwestern Medical Center | 90 | 2007-03-01 | 2025-07-25 |
| A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR Depakote ER, Depakote DR - Mania, Mixed Mania | Phase 4 | Completed | Massachusetts General Hospital | 5 | 2006-06-01 | 2007-12-06 |
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Bipolar Disorder (27) · Depression (8) · Alcoholism (3) · Psychotic Disorders (2) · Schizophrenia (2) · Anxiety Disorders (1) · Behavior, Addictive (1) · Cognitive Dysfunction (1) · Depressive Disorder, Major (1) · Mood Disorders (1) · Schizophrenia, Paranoid (1) · Substance-Related Disorders (1)
Nervous System Diseases (34) · Neurobehavioral Manifestations (34) · Neurologic Manifestations (34) · Pathological Conditions, Signs and Symptoms (34) · Signs and Symptoms (34) · Mental Disorders (29) · Bipolar and Related Disorders (27) · Mood Disorders (26) · Behavior (8) · Behavioral Symptoms (8) · Chemically-Induced Disorders (4) · Schizophrenia Spectrum and Other Psychotic Disorders (4) · Alcohol-Related Disorders (3) · Substance-Related Disorders (3) · Cognition Disorders (1)
Lithium (6) · Quetiapine Fumarate (5) · Allopurinol (3) · Olanzapine (3) · Lamotrigine (2) · Lithium Carbonate (2) · Risperidone (2) · Valproic Acid (2) · ziprasidone (2) · 10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide (1) · Acamprosate (1) · Acetylcysteine (1) · Aripiprazole (1) · Carbamazepine (1) · Chlorpromazine (1)
Massachusetts General Hospital (11) · AstraZeneca (2) · Cedars-Sinai Medical Center (2) · Medical University of South Carolina (2) · University of Pennsylvania (2) · Creighton University (1) · Eli Lilly and Company (1) · Hospital Espirita de Porto Alegre (1) · Indiana University (1) · Mclean Hospital (1) · Melbourne Health (1) · Novartis (1) · Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (1) · Shanghai Mental Health Center (1) · Taichung Veterans General Hospital (1)
United States (25) · Russia (3) · Brazil (2) · Canada (2) · Germany (2) · Poland (2) · South Africa (2) · Ukraine (2) · Australia (1) · Austria (1) · Belgium (1) · Bulgaria (1) · Colombia (1) · Czechia (1) · Guatemala (1)
Janet Wozniak, MD (5) · Joseph Biederman, MD (4) · Amit Anand, MD (2) · Kathleen T Brady, M.D., Ph.D. (2) · Robert J. DeRubeis, PhD (2) · Ana Polanco, MD (1) · Bruce Cohen, MD, PhD (1) · Bryan K Tolliver, M.D., Ph.D. (1) · Bryan K Tolliver, MD, PhD (1) · Charles Bowden, MD (1) · Chin-Hong Chan, MD.,MS. (1) · Doris Gutierrez, MD (1) · E. Sherwood Brown, MD PhD (1) · Itai Danovitch, M.D. (1)
PMID 17805214, PMID 18681754, PMID 20148867, PMID 21176032, PMID 21360754, PMID 22035648, PMID 22420596, PMID 22467848, PMID 24664811, PMID 25505693, PMID 26143402, PMID 26646031, PMID 26803764, PMID 26892848, PMID 27676420, PMID 27805299, PMID 28160351, PMID 29088928, PMID 29136600, PMID 29149756, PMID 30579045, PMID 35505312
K23AA017666 (1), R01MH060353 (1), R01MH075025 (1), R01MH080097 (1), R01MH080098 (1), U01MH068847 (1)