Bipolar DisorderPhase 3NCT00550407
An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients
A Phase 3 study testing lamotrigine in people with Bipolar Disorder, run by GlaxoSmithKline at 60 sites in Japan.
Trial summary
This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other psychotropic medication in patients with bipolar I disorder. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- lamotrigine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 60 sitesJapan
- Study dates
- Nov 2007to Oct 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At Screening Disease to be studied: Has a diagnosis of following disease as defined by DSM-IV-TR criteria.
- Bipolar I Disorder, most recent episode depressed（296.5x）
- Bipolar I Disorder, most recent episode hypomanic（296.40）
- Bipolar I Disorder, most recent episode manic（296.4x） The diagnosis of mood episode will be made with reference to Mini International Neuropsychiatric Interview: M.I.N.I, Japanese Version.
- At Screening
- The subject who has a diagnose of bipolar I disorder, most recent episode depressed (296.5x) must meet the following criteria:
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- Is currently experiencing a major depressive episode or has had a major depressive episode as defined by DSM-IV-TR criteria within 60 days of the screening visit and at least one additional major depressive episode and one manic or hypomanic episode, as defined by DSM-IV-TR criteria, within 3 years of enrolment. A well documented history of a mixed episode that meets DSM-IV-TR criteria may be counted as a previous episode.All subjects must have experienced at least one well-documented manic or mixed episode in the past.
- Has a duration of the most recent/current depressive episode of at least 2 weeks but not longer than 12 months prior to enrolment.
- The subject without current major depressive episode must have a major depressive episode within 60 days of screening and has depressive symptoms at screening or is under treatment for depressive symptoms, which can be confirmed by medical record, etc.
- If the subject is currently experiencing a major depressive episode, the subject must have a minimum total score on the HAM-D (17-item scale) of 18 at the screening. This criterion will not apply to the subject with recent depressive episode.
- At Screening
- The subject who has a diagnose of bipolar I disorder, most recent episode hypomanic（296.4x） or bipolar I disorder, most recent episode manic（296.5x） must meet the following criteria:
- Has experienced a recent manic or hypomanic episode (current or within 60 days of the Screening Visit) and has had at least one additional manic or hypomanic episode and one depressed episode, as defined by DSM-IV-TR criteria, within three years of enrolment. A well documented history of a mixed episode that meets DSM-IV-TR criteria may be counted as a previous episode. All subjects must have experienced at least one well-documented manic or mixed episode in the past.
- Has a duration of the index manic episode of at least 1 week (unless hospitalised) or hypomanic episode of at least 4 days. In neither case should the index episode be more than 12 months in duration.
- The subject current experiencing hypomania episode or without current episode must have a manic episode which can be confirmed by medical record, etc. The subject without current episode must have a episode within 60 days of screening and has manic or hypomanic symptomatology is under treatment for manic or hypomanic symptoms.
- If the subject's index episode is subject initial manic mood event, subject must have a minimum score of 10 (moderate severity) on the first 11 items of the YMRS at the screening. A threshold YMRS score that indicates significant manic symptoms is not required for patients who previously experienced well-documented DSM-IV-level mania or when the index episode is hypomania or when a subject's index manic or hypomanic episode is documented to have occurred within 60 days of the screening Visit.
- At Screening Age: Is at least 20 years of age (at the time of informed consent). At Screening Sex: either sex. Female of child-bearing potential will be eligible for inclusion in this study. However they have to have a negative pregnancy test at the screening visit, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the screening visit until the end of the follow-up examination.
- Abstinence
- Injectable progestogen
- Implants of levonorgestrel
- Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label
- Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
- Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam /gel / film / cream / suppository) At Screening In/Out patient: Either At Screening Informed consent: the subject capable of giving written informed consent. At Week 0 of First Phase (titration) If the subject is currently experiencing a major depressive episode, the subject must have a minimum total score at baseline on the HAM-D (17-item scale) of 18 at the start of First Phase. This criterion will not apply to the subject with recent depressive episode.
- At Week 0 of First Phase (titration) If the subject's index episode is subject initial manic mood event, subject must have a minimum total score at baseline of 10 (moderate severity) on the first 11 items of the YMRS at the start of First Phase (titration). A threshold YMRS score that indicates significant manic symptoms is not required for patients who previously experienced well-documented DSM-IV-level mania or when the index episode is hypomania or when a subject's index manic or hypomanic episode is documented to have occurred within 60 days of the screening Visit.
- At Week 0 of Second Phase (maintenance therapy) Each subject completing 8 to 16 weeks of open-label lamotrigine treatment in the First Phase must meet all of the following inclusion criteria to be eligible for entry into the Second Phase (maintenance therapy, randomization phase).
- At Week 0 of Second Phase (maintenance therapy) Has no tolerability problem with lamotrigine at a minimum dosage of 100 mg/day during the final 2 weeks of the First Phase (titration).
- At Week 0 of Second Phase (maintenance therapy) Has improved/stabilised during the First Phase (titration) as indicated by a CGI-S score of ≤3 (mildly ill). Once improved, the subject must also demonstrate sustained improvement by achieving a CGI-S score of ≤3 (mildly ill) for at least 4 consecutive weeks of treatment immediately prior to the Second Phase (maintenance therapy) (randomization).
- At Week 0 of Second Phase (maintenance therapy) Has demonstrated adequate compliance with the study treatment in the First Phase (titration) (compliance rate: at least 70%).
- At Week 0 of Second Phase (maintenance therapy) In/Out patient: Either
Who cannot join
- At Screening Has a DSM-IV-TR diagnosis of rapid cycling and has had more than six mood episodes including depression, mania, hypomania or mixed, in the 12-month period prior to screening. Note: while 4 or more episodes in the past 12 months constitute rapid cycling up to six episodes in the past 12 months are allowed in this protocol.
- At Screening Has a DSM-IV-TR diagnosis of bipolar I disorder, most recent episode mixed (296.6x).
- At Screening Has a DSM-IV-TR diagnosis of Axis II which would suggest non-responsiveness to pharmacotherapy for bipolar disorder.
- At Screening Has a DSM-IV-TR diagnosis of or has received treatment for major depressive disorder, panic disorder, obsessive-compulsive disorder, social phobia, bulimia nervosa, schizophrenia or schizoaffective disorder within 12 months of screening.
- At Screening Has a history of substance (including alcohol and drugs) dependence within 12 months of screening or abuse within 1 month of screening according to DSM-IV-TR.
- At Screening Patients whose mood episode is due to direct physiological effects of a general medical condition (for example, hypothyroidism, hyperthyroidism) At Screening Has a score of 3 or more on item of the HAM-D related to suicide or is at a high suicidal risk in the judgment of the investigator/sub-investigator.
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- At Screening Has a history of severe rash or rash due to anti-epileptic drugs. At Screening Patients with severe hepatic/renal/cardiac/pulmonary disorder or hematopoietic disorder. The severity refers to Grade 3 according to the Classification of the Severity of Adverse Experiences (PAB/SD Notification No. 80, dated 29 June 1992).
- At Screening Patients have less than 5 years of remission history from clinically significant malignancy (other than e.g. basal cell or squamous cell skin cancer, in-situ carcinoma of cervix or prostate CA in situ).
- At Screening Patients with chronic hepatitis typeB and /or typeC which is positive of hepatitis B surface antigen （HBsAg）and/or hepatitis C antibody.
- At Screening Has an acute or chronic illness likely to impair drug absorption, distribution, metabolism or excretion or has any unstable physical symptoms likely to require hospitalisation during participation in the study.
- At Screening Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study.
- At Screening Has a history or current diagnosis of epilepsy. At Screening Has a history of treatment with lamotrigine. At Screening Patients with a history of drug allergy to any ingredient of the test-drug. At Screening Has received an investigational drug within 30 days of screening. At Screening Is morbidly obese (Body Mass Index [BMI] >40) BMI = body weight (kg)/height (m2).
- At Screening Patients whom the investigator or sub-investigator considers ineligible for the study.
- At Week 0 of First Phase (titration) Has a score of 3 or more on item of the HAM-D related to suicide or is at a high suicidal risk in the judgment of the investigator/sub-investigator and continues .to meet the criteria at the screening visit.
- At Week 0 of Second Phase (maintenance therapy) Has signs or symptoms of psychosis. At Week 0 of Second Phase (maintenance therapy) Has a score of 3 or more on item of the HAM-D related to suicide or is at a high suicidal risk in the judgment of the investigator/sub-investigator.
- At Week 0 of Second Phase (maintenance therapy) Has had a change in lamotrigine dosage during the final week of the First Phase (titration).
- At Week 0 of Second Phase (maintenance therapy) Has a diagnosis of bipolar I disorder, most recent episode of depressed (296.5x) and has experienced manic, hypomanic or mixed symptoms; Has a diagnosis of bipolar I disorder, most recent episode hypomanic (296.40) or most recent episode manic (296.4x) and has experienced depressive symptoms, that require treatment during the First Phase (titration).
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
Japan60 sites
GSK Investigational Site
Aichi, 470-1141
GSK Investigational Site
Chiba, 260-8677
GSK Investigational Site
Chiba, 272-8516
GSK Investigational Site
Chiba, 289-2511
GSK Investigational Site
Fukuoka, 800-0217
GSK Investigational Site
Fukuoka, 802-0001
GSK Investigational Site
Fukuoka, 802-0006
GSK Investigational Site
Fukuoka, 807-8555
GSK Investigational Site
Fukuoka, 810-0004
GSK Investigational Site
Fukuoka, 812-8582
GSK Investigational Site
Fukuoka, 814-0180
GSK Investigational Site
Fukuoka, 815-0041
GSK Investigational Site
Fukuoka, 830-0011
GSK Investigational Site
Gunma, 375-0017
GSK Investigational Site
Gunma, 377-0055
GSK Investigational Site
Hiroshima, 734-8551
GSK Investigational Site
Hiroshima, 737-0023
GSK Investigational Site
Hokkaido, 002-8029
GSK Investigational Site
Hokkaido, 060-0042
GSK Investigational Site
Hokkaido, 060-8648
GSK Investigational Site
Hokkaido, 064-0946
GSK Investigational Site
Ibaraki, 311-3193
GSK Investigational Site
Kanagawa, 216-8511
GSK Investigational Site
Kanagawa, 221-0835
GSK Investigational Site
Kanagawa, 224-8503
GSK Investigational Site
Kanagawa, 225-0011
GSK Investigational Site
Kanagawa, 231-0023
GSK Investigational Site
Kanagawa, 238-0042
GSK Investigational Site
Kumamoto, 861-8002
GSK Investigational Site
Kyoto, 616-8421
GSK Investigational Site
Mie, 510-8575
GSK Investigational Site
Mie, 515-0044
GSK Investigational Site
Nara, 634-8522
GSK Investigational Site
Ōita, 874-0011
GSK Investigational Site
Ōita, 879-5593
GSK Investigational Site
Ōita, 879-7501
GSK Investigational Site
Okayama, 700-8558
GSK Investigational Site
Osaka, 533-0005
GSK Investigational Site
Osaka, 569-1041
GSK Investigational Site
Osaka, 570-8507
GSK Investigational Site
Osaka, 583-0884
GSK Investigational Site
Osaka, 590-0018
GSK Investigational Site
Saga, 842-0192
GSK Investigational Site
Saitama, 332-0012
GSK Investigational Site
Tokyo, 100-0006
GSK Investigational Site
Tokyo, 113-8603
GSK Investigational Site
Tokyo, 151-0053
GSK Investigational Site
Tokyo, 152-0012
GSK Investigational Site
Tokyo, 154-0004
GSK Investigational Site
Tokyo, 154-0012
GSK Investigational Site
Tokyo, 166-0003
GSK Investigational Site
Tokyo, 170-0002
GSK Investigational Site
Tokyo, 173-0037
GSK Investigational Site
Tokyo, 180-0005
GSK Investigational Site
Tokyo, 183-0042
GSK Investigational Site
Tokyo, 187-8551
GSK Investigational Site
Tokyo, 190-0023
GSK Investigational Site
Tottori, 680-0011
GSK Investigational Site
Tottori, 682-0023
GSK Investigational Site
Yamagata, 999-2221
About this study
Official title: Study SCA104779, an Evaluation of BW430C (Lamotrigine) Versus Placebo in the Prevention of Mood Episodes in Bipolar I Disorder Patients
This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other psychotropic medication in patients with bipolar I disorder.
- Conditions
- Bipolar Disorder
- Being tested
- lamotrigine, Placebo
- Keywords
- Lamotrigine, Prevention of relapse or recurrence of a mood episode, Bipolar I disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamotrigineDrug
lamotrigine 100mg/day or 200mg/day
PlaceboDrug
placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BW430C(lamotrigine) | Active comparator | Not described Receives: Drug: lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Withdrawal From Study
The time from randomization to the time at which the participant was withdrawn from the Double-Blind Phase of the study for any reason was measured. No data are reported for the Lamotrigine group because of an incalculable confidence interval. See the outcome measure entitled "Number of Participants with a Withdrawal Event" for data regarding the number of participants who withdrew from the study.
Measured: Randomization to Study Withdrawal (up to Week 26)
Secondary outcomes (11)
Time to Intervention for Any Mood Episode (TIME)
The TIME was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or electroconvulsive therapy (ECT) determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression or the recurrence of a manic, hypomanic, or mixed episode, whichever occurred first. Categorization as a manic, hypomanic, or mixed episode was left to the Investigator's discretion. See the outcome measure entitled "Number of Participants with Intervention for Any Mood Episode" for data related to TIME.
Measured: Randomization to Study Withdrawal (up to Week 26)
Time to Intervention for Depressive Episode (TIDep)
The TIDep was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression episode. No data are being presented for either treatment group. See the outcome measure entitled "Number of Participants with Intervention for Depressive Episode" for data related to TIDep.
Measured: Randomization to Study Withdrawal (up to Week 26)
Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan)
The TIMan was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of the relapse or recurrence of a manic, hypomanic, or mixed episode. No data are being presented for either treatment group. See the outcome measure entitled "Number of Participants with Intervention for a Manic, Hypomanic, or Mixed Episode" for data related to TIMan.
Measured: Randomization to Study Withdrawal (up to Week 26)
Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase)
The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.
Measured: Week 26/Withdrawal
Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase)
The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.
Measured: Week 16/Withdrawal
Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 26/Withdrawal (Randomized Phase)
The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).
Measured: Baseline and Week 26/Withdrawal
Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 16/Withdrawal (Preliminary Phase)
The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).
Measured: Baseline and Week 16/Withdrawal
Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)
The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).
Measured: Baseline and Week 26/Withdrawal
Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 16/Withdrawal (Preliminary Phase)
The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).
Measured: Baseline and Week 16/Withdrawal
Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase)
The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).
Measured: Baseline and Week 26/Withdrawal
Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase)
The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).
Measured: Baseline and Week 16/Withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550407
- Sponsor's protocol ID
- SCA104779
- Status last verified
- Oct 2016
- First submitted
- 26 Oct 2007
- Last updated
- 23 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Tsukasa Koyama, Teruhiko Higuchi, Shigeto Yamawaki, Shigenobu Kanba, Takeshi Terao, Atsuko Shinohara. Study SCA104779, an evaluation of BW430C (lamotrigine) versus placebo in the prevention of mood episodes in bipolar I disorder patients. Japanese Journal of Clinical Psychiatry. 2011;40(3):369-383.
Hashimoto Y, Kotake K, Watanabe N, Fujiwara T, Sakamoto S. Lamotrigine in the maintenance treatment of bipolar disorder. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013575. doi: 10.1002/14651858.CD013575.pub2.
PubMed 34523118
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study SCA104779, an Evaluation of BW430C (Lamotrigine) Versus Placebo in the Prevention of Mood Episodes in Bipolar I Disorder Patients
- ClinicalTrials.gov ID
- NCT00550407
- Acronym / sponsor ID
- SCA104779
- Conditions
- Bipolar Disorder
- Keywords
- Lamotrigine, Prevention of relapse or recurrence of a mood episode, Bipolar I disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 29 Oct 2007 (estimated)
- Results
- Posted 27 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other psychotropic medication in patients with bipolar I disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| BW430C(lamotrigine) | Active comparator | Drug: lamotrigine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- At Screening Disease to be studied: Has a diagnosis of following disease as defined by DSM-IV-TR criteria.
- Bipolar I Disorder, most recent episode depressed（296.5x）
- Bipolar I Disorder, most recent episode hypomanic（296.40）
- Bipolar I Disorder, most recent episode manic（296.4x） The diagnosis of mood episode will be made with reference to Mini International Neuropsychiatric Interview: M.I.N.I, Japanese Version.
- At Screening
Key exclusion criteria (17 listed)
- At Screening Has a DSM-IV-TR diagnosis of rapid cycling and has had more than six mood episodes including depression, mania, hypomania or mixed, in the 12-month period prior to screening. Note: while 4 or more episodes in the past 12 months constitute rapid cycling up to six episodes in the past 12 months are allowed in this protocol.
- At Screening Has a DSM-IV-TR diagnosis of bipolar I disorder, most recent episode mixed (296.6x).
- At Screening Has a DSM-IV-TR diagnosis of Axis II which would suggest non-responsiveness to pharmacotherapy for bipolar disorder.
- At Screening Has a DSM-IV-TR diagnosis of or has received treatment for major depressive disorder, panic disorder, obsessive-compulsive disorder, social phobia, bulimia nervosa, schizophrenia or schizoaffective disorder within 12 months of screening.
- At Screening Has a history of substance (including alcohol and drugs) dependence within 12 months of screening or abuse within 1 month of screening according to DSM-IV-TR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lamotriginelamotrigine 100mg/day or 200mg/day | Drug | BW430C(lamotrigine) |
| Placeboplacebo once daily | Drug | Placebo |
Primary outcome
Time to Withdrawal From Study
Time frame: Randomization to Study Withdrawal (up to Week 26)
The time from randomization to the time at which the participant was withdrawn from the Double-Blind Phase of the study for any reason was measured. No data are reported for the Lamotrigine group because of an incalculable confidence interval. See the outcome measure entitled "Number of Participants with a Withdrawal Event" for data regarding the number of participants who withdrew from the study.
11 secondary outcomes
Time to Intervention for Any Mood Episode (TIME)
Time frame: Randomization to Study Withdrawal (up to Week 26)
Time to Intervention for Depressive Episode (TIDep)
Time frame: Randomization to Study Withdrawal (up to Week 26)
Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan)
Time frame: Randomization to Study Withdrawal (up to Week 26)
Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase)
Time frame: Week 26/Withdrawal
Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase)
Time frame: Week 16/Withdrawal
Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 26/Withdrawal (Randomized Phase)
Time frame: Baseline and Week 26/Withdrawal
Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 16/Withdrawal (Preliminary Phase)
Time frame: Baseline and Week 16/Withdrawal
Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)
Time frame: Baseline and Week 26/Withdrawal
Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 16/Withdrawal (Preliminary Phase)
Time frame: Baseline and Week 16/Withdrawal
Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase)
Time frame: Baseline and Week 26/Withdrawal
Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase)
Time frame: Baseline and Week 16/Withdrawal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundTsukasa Koyama, Teruhiko Higuchi, Shigeto Yamawaki, Shigenobu Kanba, Takeshi Terao, Atsuko Shinohara. Study SCA104779, an evaluation of BW430C (lamotrigine) versus placebo in the prevention of mood episodes in bipolar I disorder patients. Japanese Journal of Clinical Psychiatry. 2011;40(3):369-383.
- Derived from this study: PubMed 34523118Hashimoto Y, Kotake K, Watanabe N, Fujiwara T, Sakamoto S. Lamotrigine in the maintenance treatment of bipolar disorder. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013575. doi: 10.1002/14651858.CD013575.pub2.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lamotrigine in people with Bipolar Disorder, run by GlaxoSmithKline at 60 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Withdrawal From Study (time frame: Randomization to Study Withdrawal (up to Week 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00550407, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.