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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00159796
First received: September 8, 2005
Last updated: September 21, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Bipolar Disorder
Drug: Asenapine
Drug: Olanzapine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Readiness for Discharge Questionnaire (RDQ) [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS) [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: Yes ]
  • Concomitant Medication Usage [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after last dose (Up to approximately 51 days) ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Each Time Point in YMRS Total Score [ Time Frame: Days 2, 4, 7, 14, and 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in the CGI-BP Severity of Depression [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21 [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Mean Change from Baseline for Vital Signs [ Time Frame: Baseline up to Day 21 ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Day 21 in Body Weight [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: Yes ]
  • Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics - Plasma asenapine concentrations [ Time Frame: Day 1 (pre-dose), 7, 14 and 21 (or endpoint) ] [ Designated as safety issue: No ]

Enrollment: 489
Study Start Date: December 2004
Study Completion Date: April 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Asenapine
Drug: Asenapine
Asenapine, 3 weeks
Other Name: Org 5222
Active Comparator: Arm 2
Olanzapine
Drug: Olanzapine
Olanzapine, 3 weeks
Placebo Comparator: Arm 3
Placebo
Drug: Placebo
placebo, 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159796

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00159796     History of Changes
Other Study ID Numbers: P07009  A7501005 
Study First Received: September 8, 2005
Last Updated: September 21, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Olanzapine
Asenapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents

ClinicalTrials.gov processed this record on September 27, 2016