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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: lamotrigine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: Study SCA104779, an Evaluation of BW430C (Lamotrigine) Versus Placebo in the Prevention of Mood Episodes in Bipolar I Disorder Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to Withdrawal From Study

Secondary outcome:

Time to Intervention for Any Mood Episode (TIME)

Time to Intervention for Depressive Episode (TIDep)

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

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

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

Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 26/Withdrawal (Randomized Phase)

Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 16/Withdrawal (Preliminary Phase)

Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)

Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 16/Withdrawal (Preliminary Phase)

Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase)

Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase)

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 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.

- 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 Exclusion Criteria: 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. 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).

Locations and Contacts

GSK Investigational Site, Aichi 470-1141, Japan

GSK Investigational Site, Chiba 260-8677, Japan

GSK Investigational Site, Chiba 272-8516, Japan

GSK Investigational Site, Chiba 289-2511, Japan

GSK Investigational Site, Fukuoka 802-0001, Japan

GSK Investigational Site, Fukuoka 830-0011, Japan

GSK Investigational Site, Fukuoka 802-0006, Japan

GSK Investigational Site, Fukuoka 807-8555, Japan

GSK Investigational Site, Fukuoka 800-0217, Japan

GSK Investigational Site, Fukuoka 812-8582, Japan

GSK Investigational Site, Fukuoka 814-0180, Japan

GSK Investigational Site, Fukuoka 815-0041, Japan

GSK Investigational Site, Fukuoka 810-0004, Japan

GSK Investigational Site, Gunma 375-0017, Japan

GSK Investigational Site, Gunma 377-0055, Japan

GSK Investigational Site, Hiroshima 734-8551, Japan

GSK Investigational Site, Hiroshima 737-0023, Japan

GSK Investigational Site, Hokkaido 002-8029, Japan

GSK Investigational Site, Hokkaido 060-0042, Japan

GSK Investigational Site, Hokkaido 060-8648, Japan

GSK Investigational Site, Ibaraki 311-3193, Japan

GSK Investigational Site, Kanagawa 225-0011, Japan

GSK Investigational Site, Kanagawa 221-0835, Japan

GSK Investigational Site, Kanagawa 224-8503, Japan

GSK Investigational Site, Kanagawa 216-8511, Japan

GSK Investigational Site, Kanagawa 231-0023, Japan

GSK Investigational Site, Kanagawa 238-0042, Japan

GSK Investigational Site, Kumamoto 861-8002, Japan

GSK Investigational Site, Kyoto 616-8421, Japan

GSK Investigational Site, Mie 510-8575, Japan

GSK Investigational Site, Mie 515-0044, Japan

GSK Investigational Site, Nara 634-8522, Japan

GSK Investigational Site, Oita 874-0011, Japan

GSK Investigational Site, Oita 879-5593, Japan

GSK Investigational Site, Oita 879-7501, Japan

GSK Investigational Site, Okayama 700-8558, Japan

GSK Investigational Site, Osaka 570-8507, Japan

GSK Investigational Site, Osaka 569-1041, Japan

GSK Investigational Site, Osaka 533-0005, Japan

GSK Investigational Site, Osaka 590-0018, Japan

GSK Investigational Site, Saga 842-0192, Japan

GSK Investigational Site, Saitama 332-0012, Japan

GSK Investigational Site, Tokyo 152-0012, Japan

GSK Investigational Site, Tokyo 113-8603, Japan

GSK Investigational Site, Tokyo 151-0053, Japan

GSK Investigational Site, Tokyo 190-0023, Japan

GSK Investigational Site, Tokyo 154-0004, Japan

GSK Investigational Site, Tokyo 154-0012, Japan

GSK Investigational Site, Tokyo 166-0003, Japan

GSK Investigational Site, Tokyo 170-0002, Japan

GSK Investigational Site, Tokyo 173-0037, Japan

GSK Investigational Site, Tokyo 100-0006, Japan

GSK Investigational Site, Tokyo 183-0042, Japan

GSK Investigational Site, Tokyo 187-8551, Japan

GSK Investigational Site, Tokyo 180-0005, Japan

GSK Investigational Site, Tottori 680-0011, Japan

GSK Investigational Site, Tottori 682-0023, Japan

GSK Investigational Site, Yamagata 999-2221, Japan

Additional Information

Related 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.

Starting date: November 2007
Last updated: May 31, 2012

Page last updated: August 23, 2015

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