An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients

NCT00550407 | Completed Phase 3 Results

• 1 other identifier: SCA104779
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 60

Brief 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.

Conditions

Bipolar Disorder

Keywords

Lamotrigine; Prevention of relapse or recurrence of a mood episode; Bipolar I disorder

Outcome Measures

Primary Outcomes (1)

• 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  The time from randomization to the time at which the participant was withdrawn from the Double-Blind Phase of the study for any reason was measured.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.

  Randomization to Study Withdrawal (up to Week 26)

Secondary Outcomes (11)

• Time to Intervention for Any Mood Episode (TIME)

  Randomization to Study Withdrawal (up to Week 26)

• Time to Intervention for Depressive Episode (TIDep)

  Randomization to Study Withdrawal (up to Week 26)

• Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan)

  Randomization to Study Withdrawal (up to Week 26)

• Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase)

  Week 26/Withdrawal

• Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase)

  Week 16/Withdrawal

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BW430C(lamotrigine)

ACTIVE COMPARATOR

Drug: lamotrigine

Interventions

lamotrigine DRUG

lamotrigine 100mg/day or 200mg/day

BW430C(lamotrigine)

Placebo DRUG

placebo once daily

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (60)

GSK Investigational Site

Aichi, 470-1141, Japan

Location

GSK Investigational Site

Chiba, 260-8677, Japan

Location

GSK Investigational Site

Chiba, 272-8516, Japan

Location

GSK Investigational Site

Chiba, 289-2511, Japan

Location

GSK Investigational Site

Fukuoka, 800-0217, Japan

Location

GSK Investigational Site

Fukuoka, 802-0001, Japan

Location

GSK Investigational Site

Fukuoka, 802-0006, Japan

Location

GSK Investigational Site

Fukuoka, 807-8555, Japan

Location

GSK Investigational Site

Fukuoka, 810-0004, Japan

Location

GSK Investigational Site

Fukuoka, 812-8582, Japan

Location

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Fukuoka, 815-0041, Japan

Location

GSK Investigational Site

Fukuoka, 830-0011, Japan

Location

GSK Investigational Site

Gunma, 375-0017, Japan

Location

GSK Investigational Site

Gunma, 377-0055, Japan

Location

GSK Investigational Site

Hiroshima, 734-8551, Japan

Location

GSK Investigational Site

Hiroshima, 737-0023, Japan

Location

GSK Investigational Site

Hokkaido, 002-8029, Japan

Location

GSK Investigational Site

Hokkaido, 060-0042, Japan

Location

GSK Investigational Site

Hokkaido, 060-8648, Japan

Location

GSK Investigational Site

Hokkaido, 064-0946, Japan

Location

GSK Investigational Site

Ibaraki, 311-3193, Japan

Location

GSK Investigational Site

Kanagawa, 216-8511, Japan

Location

GSK Investigational Site

Kanagawa, 221-0835, Japan

Location

GSK Investigational Site

Kanagawa, 224-8503, Japan

Location

GSK Investigational Site

Kanagawa, 225-0011, Japan

Location

GSK Investigational Site

Kanagawa, 231-0023, Japan

Location

GSK Investigational Site

Kanagawa, 238-0042, Japan

Location

GSK Investigational Site

Kumamoto, 861-8002, Japan

Location

GSK Investigational Site

Kyoto, 616-8421, Japan

Location

GSK Investigational Site

Mie, 510-8575, Japan

Location

GSK Investigational Site

Mie, 515-0044, Japan

Location

GSK Investigational Site

Nara, 634-8522, Japan

Location

GSK Investigational Site

Okayama, 700-8558, Japan

Location

GSK Investigational Site

Osaka, 533-0005, Japan

Location

GSK Investigational Site

Osaka, 569-1041, Japan

Location

GSK Investigational Site

Osaka, 570-8507, Japan

Location

GSK Investigational Site

Osaka, 583-0884, Japan

Location

GSK Investigational Site

Osaka, 590-0018, Japan

Location

GSK Investigational Site

Ōita, 874-0011, Japan

Location

GSK Investigational Site

Ōita, 879-5593, Japan

Location

GSK Investigational Site

Ōita, 879-7501, Japan

Location

GSK Investigational Site

Saga, 842-0192, Japan

Location

GSK Investigational Site

Saitama, 332-0012, Japan

Location

GSK Investigational Site

Tokyo, 100-0006, Japan

Location

GSK Investigational Site

Tokyo, 113-8603, Japan

Location

GSK Investigational Site

Tokyo, 151-0053, Japan

Location

GSK Investigational Site

Tokyo, 152-0012, Japan

Location

GSK Investigational Site

Tokyo, 154-0004, Japan

Location

GSK Investigational Site

Tokyo, 154-0012, Japan

Location

GSK Investigational Site

Tokyo, 166-0003, Japan

Location

GSK Investigational Site

Tokyo, 170-0002, Japan

Location

GSK Investigational Site

Tokyo, 173-0037, Japan

Location

GSK Investigational Site

Tokyo, 180-0005, Japan

Location

GSK Investigational Site

Tokyo, 183-0042, Japan

Location

GSK Investigational Site

Tokyo, 187-8551, Japan

Location

GSK Investigational Site

Tokyo, 190-0023, Japan

Location

GSK Investigational Site

Tottori, 680-0011, Japan

Location

GSK Investigational Site

Tottori, 682-0023, Japan

Location

GSK Investigational Site

Yamagata, 999-2221, Japan

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 34523118 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 29, 2007
• Study Start: November 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: November 23, 2016
• Results First Posted: July 27, 2010

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (60)