Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder facts

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.

Also known as:

A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms

Medical trial

ClinicalTrials.gov Identifier:

NCT00150553

Sponsor:

Validus Pharmaceuticals

Type of trial:

Interventional

Design:

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Primary outcomes:

Score on Young Mania Rating Scale (YMRS) at 12 weeks

Secondary outcomes:

Clinical Global Impressions Scale - Bipolar Version
HAM-D and MADRS scales for depression
Time to remission

Start date:

Jan 2005

End date:

Oct 2005

Phase:

Expected total enrollment:

Eligibile genders:

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Minimum age for eligibility:

Eligibility inclusion criteria:

DSM-IV criteria for bipolar I disorder
Screen YMRS score => 16
Women of childbearing potential agree to take adequate precautions against contraception

Eligibility exclusion criteria:

History of serious suicide attempt requiring medical intervention
Hospitalization required for treatment of psychiatric symptoms
Patients who meet DSM-IV for ultra-rapid cycling

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ClinicalTrials.gov

Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

Also known as:

Medical trial

ClinicalTrials.gov Identifier:

Sponsor:

Type of trial:

Design:

Primary outcomes:

Secondary outcomes:

Start date:

End date:

Phase:

Expected total enrollment:

Eligibile genders:

Minimum age for eligibility:

Eligibility inclusion criteria:

Eligibility exclusion criteria:

Health authority:

Diseases:

Treatment being tested:

These people have edited this topic:

midness

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Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

Also known as:

Medical trial

ClinicalTrials.gov Identifier:

Sponsor:

Type of trial:

Design:

Primary outcomes:

Secondary outcomes:

Start date:

End date:

Phase:

Expected total enrollment:

Eligibile genders:

Minimum age for eligibility:

Eligibility inclusion criteria:

Eligibility exclusion criteria:

Health authority:

Diseases:

Treatment being tested:

These people have edited this topic:

midness

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Elsewhere on the web

What is Freebase?

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