Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
265 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-08-31
Study Completion Date
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This registration study in China is a multi-centre, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of lamotrigine in the prevention of recurrence/relapse of mood episodes in subjects with bipolar I disorder. Subjects are bipolar I disorder patients with recent/current manic, hypomanic, mixed or depressive episode. The study will include an open-label phase and a randomized phase. During the open-label phase, subjects will have lamotrigine monotherapy or combination therapy escalation. The target dose of lamotrigine is 200 milligram (mg)/day monotherapy. The duration of treatment in the open-label phase will last 6-16 weeks, until subjects reach a stable dose of lamotrigine. Beginning at week 7 of the open-label phase, subjects who have reached a stable dose of lamotrigine and met response criteria, defined as maintaining a Clinical Global Impression of Severity (CGI-S) score \<= 3 for at least 4 continuous weeks and maintaining lamotrigine 200 mg/day monotherapy for at least 1 week, will be eligible to enroll in the double-blind phase of the study. Subjects who have not met response criteria after 16 weeks of participation in the open-label phase will be withdrawn from the study. Subjects will have lamotrigine 200 mg/day monotherapy for at least 1 week prior to randomization. Subjects who have met randomization requirements will be randomized 1:1 to lamotrigine 200 mg/day or placebo for 36 weeks double-blind treatment. After randomization, subjects will be assessed at weekly intervals for the first month, biweekly intervals for the second month, and then at monthly intervals for up to 36 weeks of double-blind treatment. The primary endpoint will be TIME, defined as the time to intervention (addition of pharmacotherapy or electroconvulsive therapy \[ECT\]) for any mood episode (relapse or recurrence of a depressive, manic, hypomanic or mixed episode) after randomization. The secondary endpoints will include time to intervention for manic, hypomanic or mixed episode (TIMan) and time to intervention for depressive episode (TIDep).The scores on the Hamilton Depression (HAMD), Young Mania Rating Scale (YMRS), CGI-I, CGI-S and Global Assessment Scale (GAS) will be used as indicators for both intensity and duration of mood symptoms during this phase. Subjects who withdraw early from the study prior to week 36 or reach TIME will have a follow-up visit 14 days after the last dose of investigational drug.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
NCT02513654
Bipolar Disorder
COMPLETED
PHASE1
A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium
NCT00224510
Bipolar Disorder
Bipolar Depression
COMPLETED
PHASE3
An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients
NCT00550407
Bipolar Disorder
COMPLETED
PHASE3
Bipolar Disorder Study for Men and Women
NCT00056277
Bipolar Disorder
COMPLETED
PHASE3
Depression And Bipolar Disorder
NCT00274677
Bipolar Disorder
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Bipolar Disorder
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lamotrigine CD
lamotrigine chewable dispersible tablets 25mg, 50mg, 100mg
Group Type
EXPERIMENTAL
Lamotrigine
Intervention Type
DRUG
in the double blind phase, lamotrigine 200mg/day will be used among half of eligible subjects after randomization
Placebo
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lamotrigine
in the double blind phase, lamotrigine 200mg/day will be used among half of eligible subjects after randomization
Intervention Type
DRUG
Placebo
Placebo
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
For open label phase
* Subjects must be able to effectively communicate with study personnel, have the ability to comprehend the key components of the Inform Consent Form and must provide written informed consent to participate in the study prior to any study-specific assessments or procedures.
* An in-patient or out-patient (male or female) and aged \>=18 years old.
* Disease to be studied: Has a diagnosis of the following disease as defined by DSM-IV criteria currently or within 60 days:
a)Bipolar I Disorder, most recent episode depressed (296.5x); b)Bipolar I Disorder, most recent episode hypomanic (296.40); c)Bipolar I Disorder, most recent episode manic (296.4x); d)Bipolar I Disorder, most recent episode mixed (296.6x)
* The subject who has a diagnose of "bipolar I disorder, most recent episode depressed (296.5x)" must meet the following criteria:
Has at least one well documented manic, hypomanic or mixed episode, as defined by DSM-IV criteria, within 3 years of enrolment ; The duration of recent/current depressive episode is at least 2 weeks but not longer than 12 months prior to enrolment; For subject with currently experiencing a depressive episode, he/she must have a minimum total score of 18 on the HAMD-17 at s screening.
\- The subject who has a diagnosis of "bipolar I disorder, most recent episode hypomanic (296.40)" or "bipolar I disorder, most recent episode manic (296.4x)" or "bipolar I disorder, most recent episode mixed (296.6x)" must meet the following criteria: Has had at least one well documented additional manic, hypomanic or mixed episode and one depressed episode, as defined by DSM-IV criteria, within 3 years of enrolment; Has a duration of the index manic episode of at least 1 week (unless hospitalised) or hypomanic episode of at least 4 days or mixed episode of at least 1 week. In neither case should the index episode be more than 12 months in duration; If the subject's index episode is the subject's initial/current manic mood event, subject must have a minimum score of 10 on the first 11 items of the YMRS at screening; If the subject's index episode is the subject's initial/current mixed mood event, subject must have a minimum score of 10 on the first 11 items of the YMRS, and have a minimum score of 18 on the HAMD-17 at screening.
For randomized double-blind phase
* Has been on Lamotrigine 200 mg/day monotherapy for at least 1 week.
* CGI-S score \<= 3 for at least 4 continuous weeks of treatment prior to randomization.
* Has demonstrated adequate compliance with IP (compliance rate: 75%-125%, inclusive).
* Subjects must be able to effectively communicate with study personnel, have the ability to comprehend the key components of the Inform Consent Form and must provide written informed consent to participate in the study prior to any study-specific assessments or procedures.
* An in-patient or out-patient (male or female) and aged \>=18 years old.
* Disease to be studied: Has a diagnosis of the following disease as defined by DSM-IV criteria currently or within 60 days:
a)Bipolar I Disorder, most recent episode depressed (296.5x); b)Bipolar I Disorder, most recent episode hypomanic (296.40); c)Bipolar I Disorder, most recent episode manic (296.4x); d)Bipolar I Disorder, most recent episode mixed (296.6x)
* The subject who has a diagnose of "bipolar I disorder, most recent episode depressed (296.5x)" must meet the following criteria:
Has at least one well documented manic, hypomanic or mixed episode, as defined by DSM-IV criteria, within 3 years of enrolment ; The duration of recent/current depressive episode is at least 2 weeks but not longer than 12 months prior to enrolment; For subject with currently experiencing a depressive episode, he/she must have a minimum total score of 18 on the HAMD-17 at s screening.
\- The subject who has a diagnosis of "bipolar I disorder, most recent episode hypomanic (296.40)" or "bipolar I disorder, most recent episode manic (296.4x)" or "bipolar I disorder, most recent episode mixed (296.6x)" must meet the following criteria: Has had at least one well documented additional manic, hypomanic or mixed episode and one depressed episode, as defined by DSM-IV criteria, within 3 years of enrolment; Has a duration of the index manic episode of at least 1 week (unless hospitalised) or hypomanic episode of at least 4 days or mixed episode of at least 1 week. In neither case should the index episode be more than 12 months in duration; If the subject's index episode is the subject's initial/current manic mood event, subject must have a minimum score of 10 on the first 11 items of the YMRS at screening; If the subject's index episode is the subject's initial/current mixed mood event, subject must have a minimum score of 10 on the first 11 items of the YMRS, and have a minimum score of 18 on the HAMD-17 at screening.
For randomized double-blind phase
* Has been on Lamotrigine 200 mg/day monotherapy for at least 1 week.
* CGI-S score \<= 3 for at least 4 continuous weeks of treatment prior to randomization.
* Has demonstrated adequate compliance with IP (compliance rate: 75%-125%, inclusive).
Exclusion Criteria
For open label
* Has met Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for rapid cycling and has had more than 4 manic, hypomanic, mixed or depressive episodes in the 12-month period prior to enrollment.
* Has a significant DSM-IV Axis II diagnosis which would suggest non-responsiveness to pharmacotherapy for bipolar disorder or non-compliance with the protocol.
* Has a current or previous diagnosis of an Axis I disorder (including anorexia nervosa or bulimia nervosa) with the exception of bipolar disorder or has received corresponding treatment, or has been diagnosed with dysthymia within the previous 2 years.
* Has signs or symptoms of psychosis.
* The subject, in the investigator's judgment, poses a suicidal risk, has attempted suicide within 6 months prior to screening (assessed using the Columbia Suicide Severity Rating Scale Baseline) or .
* Has documented Intelligence quotient \< 70 or suspected mental retardation.
* Has a history of substance abuse or dependence within 12 months prior to enrolment (DSM-IV defined substance categories, excluding nicotine and caffeine and including alcohol), or has as a positive urine test for illicit drug use (excluding nicotine and caffeine).
* Has received fluoxetine within 4 weeks prior to entry into the open-label phase; has received oral contraceptives or other hormonal preparations containing estrogen within 2 weeks prior to entry into the open-label phase; has received lopinavir/ritonavir or atazanavir /ritonavir within 7 days prior to the baseline visit.
* Has a clinically significant and/or unstable medical disorder (with or without lab test results); or clinically significant test results (thyroid function, electrocardiogram, hematology, clinical chemistry, or urinalysis) as per investigator's judgment; or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of lamotrigine; per investigator's clinical judgment (after consulting GSK medical monitor), might pose a safety concern; or interfere with the accurate assessment of safety or efficacy.
* Has a history or current diagnosis of epilepsy.
* Is morbidly obese, i.e. if Body Mass Index (BMI) is \> 35 {BMI = Body weight (in kg) divided by (Height in meters squared).
* Single or average QT interval corrected by Bazette's formulaQTcB or QTc \> 450 millisecond (msec); for patients with bundle branch block QTc \> 480 msec.
* Has a history of hepatic dysfunction; Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>= 2 x upper limit of normal (ULN); Alkaline phosphatase (ALP) or total bilirubin \> 1.5 x ULN (excluding total bilirubin \> 1.5 x ULN but direct bilirubin \< 35%) or other conditions which, in the investigator's judgment, would render patients unsuitable for the study.
* Has a history of drug allergy (including rash) or a medically significant adverse effect from any ingredient of lamotrigine, or a history of rash due to anti-epileptic drugs or has frequent and/or serious hypersensitivity reaction to multiple drugs.
* Participation in any study related to lamotrigine within 6 months before screening or has received lamotrigine within 4 weeks before screening.
* Participation in another clinical study unrelated to the current illness currently or within the previous 30 days, or 3 months for studies related to the current illness.
* Initiation of systematic psychotherapy within 3 months prior to screening or planned initiation of systematic psychotherapy during the study.
* Female subjects who are pregnant, lactating or do not agree to use the contraceptive methods such as use of condom, injection of progesterone, a reliable barrier method of birth control, partner with vasectomy or abstinence during the study.
For randomized double blind phase
* Has signs or symptoms of psychosis.
* Requires treatment for a manic or mixed episode in the open-label phase with new courses of lithium, psychotropic drugs or other drugs with a half-life greater than 14 days.
* Has become actively suicidal and/or has a score \>=3 on item 3 of the HAMD.
* Has tested positive for an illicit drug on lab analysis administered before randomization or alcohol abuse/addiction.
* Has had a change in lamotrigine dosage during the last week of the open-label phase.
* Has met Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for rapid cycling and has had more than 4 manic, hypomanic, mixed or depressive episodes in the 12-month period prior to enrollment.
* Has a significant DSM-IV Axis II diagnosis which would suggest non-responsiveness to pharmacotherapy for bipolar disorder or non-compliance with the protocol.
* Has a current or previous diagnosis of an Axis I disorder (including anorexia nervosa or bulimia nervosa) with the exception of bipolar disorder or has received corresponding treatment, or has been diagnosed with dysthymia within the previous 2 years.
* Has signs or symptoms of psychosis.
* The subject, in the investigator's judgment, poses a suicidal risk, has attempted suicide within 6 months prior to screening (assessed using the Columbia Suicide Severity Rating Scale Baseline) or .
* Has documented Intelligence quotient \< 70 or suspected mental retardation.
* Has a history of substance abuse or dependence within 12 months prior to enrolment (DSM-IV defined substance categories, excluding nicotine and caffeine and including alcohol), or has as a positive urine test for illicit drug use (excluding nicotine and caffeine).
* Has received fluoxetine within 4 weeks prior to entry into the open-label phase; has received oral contraceptives or other hormonal preparations containing estrogen within 2 weeks prior to entry into the open-label phase; has received lopinavir/ritonavir or atazanavir /ritonavir within 7 days prior to the baseline visit.
* Has a clinically significant and/or unstable medical disorder (with or without lab test results); or clinically significant test results (thyroid function, electrocardiogram, hematology, clinical chemistry, or urinalysis) as per investigator's judgment; or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of lamotrigine; per investigator's clinical judgment (after consulting GSK medical monitor), might pose a safety concern; or interfere with the accurate assessment of safety or efficacy.
* Has a history or current diagnosis of epilepsy.
* Is morbidly obese, i.e. if Body Mass Index (BMI) is \> 35 {BMI = Body weight (in kg) divided by (Height in meters squared).
* Single or average QT interval corrected by Bazette's formulaQTcB or QTc \> 450 millisecond (msec); for patients with bundle branch block QTc \> 480 msec.
* Has a history of hepatic dysfunction; Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>= 2 x upper limit of normal (ULN); Alkaline phosphatase (ALP) or total bilirubin \> 1.5 x ULN (excluding total bilirubin \> 1.5 x ULN but direct bilirubin \< 35%) or other conditions which, in the investigator's judgment, would render patients unsuitable for the study.
* Has a history of drug allergy (including rash) or a medically significant adverse effect from any ingredient of lamotrigine, or a history of rash due to anti-epileptic drugs or has frequent and/or serious hypersensitivity reaction to multiple drugs.
* Participation in any study related to lamotrigine within 6 months before screening or has received lamotrigine within 4 weeks before screening.
* Participation in another clinical study unrelated to the current illness currently or within the previous 30 days, or 3 months for studies related to the current illness.
* Initiation of systematic psychotherapy within 3 months prior to screening or planned initiation of systematic psychotherapy during the study.
* Female subjects who are pregnant, lactating or do not agree to use the contraceptive methods such as use of condom, injection of progesterone, a reliable barrier method of birth control, partner with vasectomy or abstinence during the study.
For randomized double blind phase
* Has signs or symptoms of psychosis.
* Requires treatment for a manic or mixed episode in the open-label phase with new courses of lithium, psychotropic drugs or other drugs with a half-life greater than 14 days.
* Has become actively suicidal and/or has a score \>=3 on item 3 of the HAMD.
* Has tested positive for an illicit drug on lab analysis administered before randomization or alcohol abuse/addiction.
* Has had a change in lamotrigine dosage during the last week of the open-label phase.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Guangzhou, Guangdong, China
Site Status
GSK Investigational Site
Guangzhou, Guangdong, China
Site Status
GSK Investigational Site
Guangzhou, Guangdong, China
Site Status
GSK Investigational Site
Baoding, Hebei, China
Site Status
GSK Investigational Site
Shijiazhuang, Hebei, China
Site Status
GSK Investigational Site
Harbin, Heilongjiang, China
Site Status
GSK Investigational Site
Changshacun, Henan, China
Site Status
GSK Investigational Site
Xinxiang, Henan, China
Site Status
GSK Investigational Site
Wuhan, Hubei, China
Site Status
GSK Investigational Site
Changsha, Hunan, China
Site Status
GSK Investigational Site
Nanjing, Jiangsu, China
Site Status
GSK Investigational Site
Xi'an, Shaanxi, China
Site Status
GSK Investigational Site
Taiyuan, Shanxi, China
Site Status
GSK Investigational Site
Chengdu, Sichuan, China
Site Status
GSK Investigational Site
Kunming, Yunnan, China
Site Status
GSK Investigational Site
Hangzhou, Zhejiang, China
Site Status
GSK Investigational Site
Hangzhou, Zhejiang, China
Site Status
GSK Investigational Site
Beijing, , China
Site Status
GSK Investigational Site
Beijing, , China
Site Status
GSK Investigational Site
Beijing, , China
Site Status
GSK Investigational Site
Shanghai, , China
Site Status
Countries
Review the countries where the study has at least one active or historical site.
China
References
Explore related publications, articles, or registry entries linked to this study.
Zhang L, Zhang H, Lv LX, Tan Q, Xu X, Hu J, Zi L, Cooper J, Phansalkar A, Wang G. A randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of lamotrigine in the maintenance treatment of Chinese adult patients with bipolar I disorder. Int J Bipolar Disord. 2022 Aug 1;10(1):20. doi: 10.1186/s40345-022-00266-4.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
113783
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
NCT05169710
TERMINATED
PHASE3
A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -
NCT00566020
COMPLETED
PHASE3
Lamotrigine Therapy in Geriatric Bipolar Depression
NCT00720473
COMPLETED
NA
Bipolar Study in Adults at Least 18 Years of Age
NCT00067938
COMPLETED
PHASE4
Observation Study of the Clinical Management of Bipolar Disorder
NCT01770704
COMPLETED
An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
NCT00360126
COMPLETED
PHASE4
Lamotrigine for Symptoms of Geriatric Bipolar Depression
NCT00621842
COMPLETED
PHASE3
Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine
NCT02989727
COMPLETED
PHASE4
Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression
NCT00475137
COMPLETED
PHASE2
Special Drug Use Investigation for LAMICTAL Bipolar
NCT01428518
COMPLETED
Lamotrigine Monotherapy in Pediatric Bipolar Disorder
NCT00176228
COMPLETED
PHASE2
A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
NCT00907985
TERMINATED
PHASE1
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
NCT03249376
COMPLETED
PHASE3
Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
NCT00305578
COMPLETED
PHASE4
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
NCT04285515
COMPLETED
PHASE3
Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
NCT00634062
COMPLETED
PHASE4
Lamictal Bipolar Observational Study
NCT00460226
COMPLETED
Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)
NCT01396291
COMPLETED
PHASE3
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
NCT01986101
COMPLETED
PHASE3
Prophylactic Effect of Lamotrigine Compared With Lithium in Bipolar Disorder
NCT00226135
COMPLETED
PHASE3
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
NCT01072630
COMPLETED
PHASE3
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
NCT00723450
COMPLETED
PHASE3
A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression
NCT03543410
COMPLETED
PHASE2
A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).
NCT05227209
TERMINATED
PHASE3
Treatment of Alcohol Dependence and Comorbid Bipolar Disorder
NCT01015586
COMPLETED
PHASE4