Mania Clinical Trial
Official title:
A Comparison Study of the Efficacy and Tolerability Between Depakote ER and Depakote in the Acute Treatment of Mania and Mixed Mania
To compare the time to response, response rates, remission rates, and side effects in Bipolar Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.
There are several studies demonstrating the efficacy of divalproex in the acute treatment of mania and mixed mania. In fact, the American Psychiatric Associations Practice Guidelines for Bipolar Disorder recommends divalproex as a first-line treatment for acute mania and acute mixed mania; divalproex is the treatment of choice in the treatment of acute mixed mania. The Food and Drug Administration (FDA) approved divalproex for the acute treatment of mania in the 1990's. A new formulation, divalproex, Depakote ER, was recently FDA approved for the treatment of epilepsy and prophylaxis of migraine headaches. In a pooled data analysis of nine open-labeled trials involving 321 epilepsy and bipolar disorder patients, Smith et al. that Depakote ER was associated with superior tolerability including less frequent tremors, weight gain, and gastrointestinal complaints (all p<0.001) compared with Depakote DR. Depakote ER was preferred by subjects and it provided improved seizure control and a greater reduction in psychiatric symptoms. ;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05206747 -
Ottawa Sunglasses at Night for Mania Study
|
N/A | |
Completed |
NCT00534222 -
Unraveling the Relation of Patient's Profile and Therapeutical Effects of Atypicals, Including Quetiapine Effect
|
N/A | |
Completed |
NCT00140179 -
Valnoctamide in Mania
|
Phase 3 | |
Completed |
NCT01237379 -
Peroxisomal Defects and Familial Risk for Bipolar Disorder
|
N/A | |
Completed |
NCT01315028 -
Bipolar Intervention Study: Cognitive Interpersonal Therapy
|
N/A | |
Completed |
NCT00254488 -
Treatment of Bipolar Mania in Older Adults
|
Phase 4 | |
Completed |
NCT00560079 -
Efficacy of Allopurinol and Dypiridamole in Acute Mania
|
Phase 4 | |
Completed |
NCT00518947 -
Pharmacotherapy of Treatment-Resistant Mania
|
Phase 3 | |
Recruiting |
NCT05444907 -
Deep Brain Stimulation-Induced Mania in Parkinson's Disease
|
||
Enrolling by invitation |
NCT02360267 -
Pediatric Bipolar Registry
|
||
Completed |
NCT01092221 -
Allopurinol for Mania: A Randomized Trial Administering Allopurinol vs. Placebo as add-on to Mood Stabilizers and/or Antipsychotics in Patients in a Bipolar Manic Episode
|
Phase 3 | |
Completed |
NCT00521365 -
Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.
|
Phase 4 | |
Completed |
NCT01191918 -
The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania
|
Phase 4 | |
Completed |
NCT01541605 -
Methylphenidate for the Treatment of Acute Mania
|
Phase 3 | |
Completed |
NCT00893581 -
Multimodal Neuroimaging of Treatment Effects in Adolescent Mania
|
N/A | |
Completed |
NCT00208195 -
Depakote ER Therapy for Mania Comorbid With Substance Abuse
|
Phase 4 | |
Completed |
NCT00181922 -
Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
|
Phase 4 | |
Completed |
NCT00181935 -
Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder
|
Phase 4 | |
Active, not recruiting |
NCT05703711 -
Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa
|
N/A | |
Completed |
NCT00917501 -
Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania
|
Phase 2 |