3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

Bipolar Disorder Clinical Trial

Official title:

A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual Asenapine vs. Olanzapine and Placebo in In-Patients With an Acute Manic Episode Clinical Trial Protocol 7501005 (Secondary Title: ARES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159796
• Other study ID #: P07009
• Secondary ID: A7501005
• Status: Completed
• Phase: Phase 3
• Start date: December 14, 2004
• Est. completion date: April 28, 2006

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. This is a 3-week study that will test the safety and efficacy of this medication. Participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Participants will be required to stay in the hospital for at least the first seven days of treatment. Participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: April 28, 2006
• Est. primary completion date: March 28, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.

Exclusion Criteria:

• Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Asenapine
Asenapine, 3 weeks
• Olanzapine
Olanzapine, 3 weeks
• Placebo
placebo, 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score		Baseline to Day 21
Secondary	Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania		Baseline to Day 21
Secondary	Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score		Baseline to Day 21
Secondary	Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score		Baseline to Day 21
Secondary	Readiness for Discharge Questionnaire (RDQ)		Baseline to Day 21
Secondary	Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs		Baseline to Day 21
Secondary	Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores		Baseline to Day 21
Secondary	Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS)		Baseline to Day 21
Secondary	Concomitant Medication Usage		Up to Day 21
Secondary	Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to 30 days after last dose (Up to approximately 51 days)
Secondary	Change from Baseline to Each Time Point in YMRS Total Score		Days 2, 4, 7, 14, and 21
Secondary	Change from Baseline to Day 21 in the CGI-BP Severity of Depression		Baseline to Day 21
Secondary	Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness		Baseline to Day 21
Secondary	Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores		Baseline to Day 21
Secondary	Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21		Day 21
Secondary	Mean Change from Baseline for Vital Signs		Baseline up to Day 21
Secondary	Change from Baseline to Day 21 in Body Weight		Baseline to Day 21
Secondary	Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values		Up to Day 21
Secondary	Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values		Up to Day 21
Secondary	Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values		Up to Day 21
Secondary	Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values		Up to Day 21
Secondary	Pharmacokinetics - Plasma asenapine concentrations		Day 1 (pre-dose), 7, 14 and 21 (or endpoint)