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Trial record 77 of 215 for:    Lamotrigine

A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

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ClinicalTrials.gov Identifier: NCT00277212
Recruitment Status : Completed
First Posted : January 16, 2006
Results First Posted : October 20, 2010
Last Update Posted : December 2, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lamotrigine + Aripiprazole Drug: Lamotrigine + Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode
Study Start Date : December 2005
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A1
Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole
Drug: Lamotrigine + Aripiprazole

Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks

Lamotrigine 100-200 mg/day

Aripiprazole 10-30 mg/day

Other Names:
  • Abilify
  • BMS-337039

Placebo Comparator: A2
Phase 2 Double-Blind Treatment: Lamotrigine + Placebo
Drug: Lamotrigine + Placebo

Tablets, Oral, once daily, Phase 2 - up to 52 weeks

Lamotrigine 100-200 mg/day

placebo 0 mg/day





Primary Outcome Measures :
  1. Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) [ Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
    Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).


Secondary Outcome Measures :
  1. Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2 [ Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
    Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).

  2. Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2) [ Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
    Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).

  3. Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2) [ Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
    Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate).

  4. Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs [ Time Frame: Throughout Phase 2 (up to 52 weeks) ]
    AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.

  5. Adjusted Mean Change From Baseline in Body Weight, Phase 2 [ Time Frame: Baseline, Week 52 ]
    Adjusted for index mood episode and baseline assessment

  6. Number of Participants Showing Clinically Relevant Weight Loss by Study Week [ Time Frame: Weeks 12, 24, 36, 52 ]
    Weight Loss of at least a 7% decrease from Baseline.

  7. Number of Participants Showing Clinically Relevant Weight Gain by Study Week [ Time Frame: Weeks 12, 24, 36, 52 ]
    Weight gain of at least a 7% increase from Baseline.

  8. Adjusted Mean Change From Baseline in BMI by Study Week [ Time Frame: Baseline, Weeks 12, 24, 36, 52 ]
    Adjusted for index mood episode and baseline assessment.

  9. Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment [ Time Frame: Throughout the study, up to Week 52 ]
    Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm & no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm & no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec & no current diagnosis of left or right bundle branch block.

  10. Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment [ Time Frame: Up to 52 Weeks ]
    In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient's pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15.

  11. Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2) [ Time Frame: Throughout Phase 2 of the study, up to Week 52 ]
    Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL)

  12. Summary of Concomitant Medications, Phase 1 [ Time Frame: Phase 1 (9 to 24 Week Single-blind Stabilization Phase) ]
  13. Summary of Concomitant Medications, Phase 2 [ Time Frame: Phase 2 (52 Week Double-blind Relapse Assessment Phase) ]
  14. Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score [ Time Frame: Baseline, Weeks 8, 24, 36, 52 ]
    The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.

  15. Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score [ Time Frame: Baseline, Weeks 8, 24, 36, 52 ]
    The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.

  16. Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment, [ Time Frame: Baseline, Weeks 8, 24, 36, 52 ]
    The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic

Exclusion Criteria:

  • First manic episode
  • Current manic or mixed episode with > 2 years duration
  • Treated with aripiprazole within the past 3 months
  • Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277212


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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00277212     History of Changes
Other Study ID Numbers: CN138-392 ST
First Posted: January 16, 2006    Key Record Dates
Results First Posted: October 20, 2010
Last Update Posted: December 2, 2013
Last Verified: November 2010
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Bipolar I Disorder with a recent manic or mixed episode
Additional relevant MeSH terms:
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Lamotrigine
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Aripiprazole
Anticonvulsants
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Sodium Channel Blockers