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Completed

NCT Number: NCT00159796

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

asenapine

Drug

Asenapine, 3 weeks

Other names: Org 5222

Olanzapine

Drug

Olanzapine, 3 weeks

Placebo

Drug

placebo, 3 weeks

Primary outcomes

  1. Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score

    Time frame: Baseline to Day 21

Secondary outcomes

  1. 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

  2. Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score

    Time frame: Baseline to Day 21

  3. Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: Baseline to Day 21

  4. Readiness for Discharge Questionnaire (RDQ)

    Time frame: Baseline to Day 21

  5. Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs

    Time frame: Baseline to Day 21

  6. Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores

    Time frame: Baseline to Day 21

  7. Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS)

    Time frame: Baseline to Day 21

  8. Concomitant Medication Usage

    Time frame: Up to Day 21

  9. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 30 days after last dose (Up to approximately 51 days)

  10. Change from Baseline to Each Time Point in YMRS Total Score

    Time frame: Days 2, 4, 7, 14, and 21

  11. Change from Baseline to Day 21 in the CGI-BP Severity of Depression

    Time frame: Baseline to Day 21

  12. Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness

    Time frame: Baseline to Day 21

  13. Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores

    Time frame: Baseline to Day 21

  14. Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21

    Time frame: Day 21

  15. Mean Change from Baseline for Vital Signs

    Time frame: Baseline up to Day 21

  16. Change from Baseline to Day 21 in Body Weight

    Time frame: Baseline to Day 21

  17. Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values

    Time frame: Up to Day 21

  18. Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values

    Time frame: Up to Day 21

  19. Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values

    Time frame: Up to Day 21

  20. Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values

    Time frame: Up to Day 21

  21. Pharmacokinetics - Plasma asenapine concentrations

    Time frame: Day 1 (pre-dose), 7, 14 and 21 (or endpoint)

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Collaborators

  • Pfizer

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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