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| Sponsor: | Validus Pharmaceuticals |
|---|---|
| Information provided by: | Validus Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00150605 |
Purpose
The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Extended-release carbamazepine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | October 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | SPD417-308 |
| Study First Received: | September 6, 2005 |
| Last Updated: | November 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00150605 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Tranquilizing Agents Disease Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Pharmacologic Actions Affective Disorders, Psychotic Pathologic Processes |
Carbamazepine Mental Disorders Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Mood Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |