Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
NCT00150553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2007-11-02
Summary
The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.
Conditions
Interventions
- DRUG
-
Extended-release carbamazepine
Sponsors & Collaborators
-
Validus Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Completion
- 2005-10-31
More Related Trials
-
An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
NCT00106405 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Cariprazine for Bipolar I Disorder
NCT01058668 ·Status: COMPLETED ·Phase: PHASE3
-
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
NCT00194116 ·Status: COMPLETED ·Phase: PHASE3
-
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
NCT07288320 ·Status: RECRUITING ·Phase: PHASE2
-
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.
NCT00154323 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder
NCT00240721 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
NCT01396447 ·Status: COMPLETED ·Phase: PHASE2
-
A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder
NCT00037674 ·Status: COMPLETED ·Phase: PHASE3
-
VALID : VAlproate Versus LIthium in Bipolar Disorders
NCT00264173 ·Status: COMPLETED ·Phase: PHASE4
-
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
NCT00228059 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
NCT00099229 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
NCT05169710 ·Status: TERMINATED ·Phase: PHASE3
-
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
NCT00060905 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Cariprazine for Mania
NCT01058096 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
NCT00107926 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Combined Treatment for Young Bipolar I Disorder
NCT00976794 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder
NCT00374920 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
NCT00035802 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
NCT06951698 ·Status: RECRUITING ·Phase: PHASE3
-
A Double-Blind, Placebo-Controlled Study of Galantamine to Improve Cognitive Dysfunction in Bipolar Disorder
NCT00195845 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-release Paliperidone in Subjects With Bipolar I Disorder
NCT00299715 ·Status: COMPLETED ·Phase: PHASE3
-
An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients
NCT00550407 ·Status: COMPLETED ·Phase: PHASE3
-
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder
NCT00238485 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
NCT03692910 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of Lithium in Bipolar Disorder
NCT00422331 ·Status: UNKNOWN ·Phase: PHASE3