40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

NCT00159783 | Completed Phase 3 Results DMC

• 2 other identifiers: P05857A7501007
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bipolar disorder is characterized by mood swings that range from 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. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (9)

• Participants Who Experienced Adverse Event(s)

  Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

  Up to 40 weeks

• Number of Participants With Abnormal Physical Examination Findings

  Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm \& rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.

  Week 40 or endpoint

• Number of Participants With Abnormal Electrocardiogram

  This is the number of participants with electrocardiogram (ECG) adverse events.

  Week 40 or endpoint

• Body Weight

  Weight change from baseline

  Baseline to Week 40 or endpoint

• Extrapyramidal Symptoms [EPS]

  EPS was assessed using the (1) involuntary movement scale \[AIMS\], (2) Barnes Akathisia Rating Scale \[BARS\], and (3) Simpson Angus Rating Scale SARS. AIMS score range 0-4; higher scores indicate greater symptom severity. BARS score rang 0-9; higher scores indicate greater severity of akathisia. SARS score range 0-40; higher scores indicate greater degree of Parkinsonism.

  Week 40 or endpoint

• Concomitant Medications

  Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of last dose of double-blind study drug.

  Up to 40 weeks

• Abdominal Girth

  Change in abdominal girth from baseline

  Baseline to Week 40 or endpoint

• Number of Participants With Markedly Abnormal Vital Sign Changes

  Vital signs measured: sitting blood pressure, heart rate. Definitions: Markedly abnormal decreases: heart rate (HR) - if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) - if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) - if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg. Markedly abnormal increases: HR - if ≥110 bpm and increase from baseline of ≥15 bpm; SBP - if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP - if ≥105 mm Hg and increase from baseline of ≥15 mm Hg.

  Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)

• Number of Participants With Laboratory Values Outside Normal Range

  Normal ranges were provided by the central laboratory. Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin Endocrinology/miscellaneous = insulin, prolactin Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils

  Week 40 or endpoint

Study Arms (2)

Asenapine

EXPERIMENTAL

Asenapine 5-10 mg twice daily for 40 weeks

Drug: asenapine

Olanzapine

ACTIVE COMPARATOR

Olanzapine 5-20 mg once daily for 40 weeks

Drug: Olanzapine

Interventions

asenapine DRUG

Asenapine, 40 weeks

Also known as: Org 5222

Asenapine

Olanzapine DRUG

Olanzapine, 40 weeks

Olanzapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..

You may not qualify if:

• Patients with unstable medical conditions or clinically significant laboratory
• abnormalities.

Sponsors & Collaborators

• Organon and Co: lead
• Pfizer: collaborator

Related Publications (1)

• McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord. 2010 Nov;126(3):358-65. doi: 10.1016/j.jad.2010.04.005.

  PMID: 20537396 RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

asenapine; Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: February 9, 2022
• Results First Posted: July 16, 2010

Record last verified: 2022-02