CLINICAL TRIALS PROFILE FOR ESKALITH CR

All Clinical Trials for Eskalith Cr

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00057681 ↗	Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents	Completed	National Institute of Mental Health (NIMH)	Phase 3	2003-02-01	This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
NCT00057681 ↗	Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents	Completed	Washington University School of Medicine	Phase 3	2003-02-01	This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
NCT00221975 ↗	Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling	Completed	University Hospitals Cleveland Medical Center	Phase 3	2002-07-01	Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol within the past six months. Patients begin treatment with a combination of lithium and divalproex. Once these medications are tolerated, they are randomly assigned to double-blind treatment with lamotrigine or placebo. Patients remain in this study until they experience a marked bimodal response for four consecutive weeks. This study is sponsored by the Stanley Foundation.
NCT00408681 ↗	Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant	Completed	National Cancer Institute (NCI)	N/A	2006-06-01	RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
NCT00408681 ↗	Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant	Completed	Fred Hutchinson Cancer Research Center	N/A	2006-06-01	RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.
NCT00601575 ↗	Bioequivalency Study of 450 mg Lithium Carbonate Under Fed Conditions	Completed	Roxane Laboratories	N/A	2002-10-01	The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fed conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.
NCT00602381 ↗	Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions	Completed	Roxane Laboratories	N/A	2002-11-01	The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fasting conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.

Clinical Trial Conditions for Eskalith Cr

Condition Name

Condition Name for Eskalith Cr
Intervention	Trials
Bipolar Disorder	7
Recurrent Adult Acute Myeloid Leukemia	2
Treatment-Refractory Depression	2
Late Life Depression	2

Condition MeSH

Condition MeSH for Eskalith Cr
Intervention	Trials
Bipolar Disorder	8
Depressive Disorder, Major	3
Depressive Disorder	3
Depression	3

Clinical Trial Locations for Eskalith Cr

Trials by Country

Trials by Country for Eskalith Cr
Location	Trials
United States	28
Canada	3
Sweden	2
Norway	1

Trials by US State

Trials by US State for Eskalith Cr
Location	Trials
Ohio	4
California	3
Pennsylvania	3
Missouri	3
New York	2

Clinical Trial Progress for Eskalith Cr

Clinical Trial Phase

Clinical Trial Phase for Eskalith Cr
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Eskalith Cr
Clinical Trial Phase	Trials
Completed	10
Terminated	1
Active, not recruiting	1

Clinical Trial Sponsors for Eskalith Cr

Sponsor Name

Sponsor Name for Eskalith Cr
Sponsor	Trials
National Institute of Mental Health (NIMH)	5
Roxane Laboratories	2
Washington University School of Medicine	2

Sponsor Type

Sponsor Type for Eskalith Cr
Sponsor	Trials
Other	13
NIH	7
Industry	2