Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder

V

Validus Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Extended-release carbamazepine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150605
SPD417-308

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* DSM-IV criteria for Bipolar I disorder * Screening YMRS score =\>16 * Women of childbearing potential agree to take adequate precautions against contraception * Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic

Exclusion criteria

* Hospitalization required for treatment of psychiatric symptoms * Patients who meet DSM-IV for ultra-rapid cycling * History of serious suicide attempt requiring medical intervention * Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems