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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00550407

First received: October 26, 2007

Last updated: May 31, 2012

Last verified: June 2011

History of Changes

Results First Received: May 24, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Bipolar Disorder
Interventions:	Drug: lamotrigine Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants whose symptoms of mood episodes were stabilized with lamotrigine in the Preliminary Phase (Clinical Global Impressions of Severity score of 3 [mild] or less for at least 4 consecutive weeks, and lamotrigine given as monotherapy for at least 1 week before the start of the Randomized Phase) were randomized to placebo or lamotrigine.

Reporting Groups

	Description
Lamotrigine 25-200 mg	The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
Placebo	Matching placebo
Lamotrigine 200 mg	Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.

Participant Flow for 2 periods

Period 1: 8-16 Week Preliminary (Open-Label) Phase

	Lamotrigine 25-200 mg	Placebo	Lamotrigine 200 mg
STARTED	215	0	0
COMPLETED	103	0	0
NOT COMPLETED	112	0	0
Adverse Event	55	0	0
Lack of Efficacy	39	0	0
Protocol Violation	1	0	0
Defined Stopping Criteria Reached	1	0	0
Lost to Follow-up	1	0	0
Investigator Discretion	8	0	0
Withdrew Consent	6	0	0
Continuation Criteria Not Met	1	0	0

Period 2: 26-Week Randomized Phase

	Placebo	Lamotrigine 200 mg
STARTED	58	45
COMPLETED	15	21
NOT COMPLETED	43	24
Adverse Event	5	2
Lack of Efficacy	36	19
Investigator Discretion	1	0
Withdrawal by Subject	1	3

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Matching placebo
Lamotrigine 200 mg	Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Lamotrigine 200 mg	Total
Number of Participants [units: participants]	58	45	103
Age [units: years] Mean ± Standard Deviation	43.1 ± 12.68	42.4 ± 11.79	42.8 ± 12.25
Gender [units: participants]
Female	31	27	58
Male	27	18	45
Race/Ethnicity, Customized [units: participants]
Asian－Japanese Heritage	58	44	102
Asian－East Asian Heritage	0	1	1

Outcome Measures

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1. Primary:

Time to Withdrawal From Study [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]

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2. Secondary:

Time to Intervention for Any Mood Episode (TIME) [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]

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3. Secondary:

Time to Intervention for Depressive Episode (TIDep) [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]

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4. Secondary:

Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan) [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]

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5. Secondary:

Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase) [ Time Frame: Week 26/Withdrawal ]

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6. Secondary:

Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase) [ Time Frame: Week 16/Withdrawal ]

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7. Secondary:

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 ]

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8. Secondary:

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 ]

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9. Secondary:

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 ]

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Measure Type	Secondary
Measure Title	Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)
Measure Description	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).
Time Frame	Baseline and Week 26/Withdrawal
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS2

Reporting Groups

	Description
Placebo	Matching placebo
Lamotrigine 200 mg	Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.

Measured Values

	Placebo	Lamotrigine 200 mg
Number of Participants Analyzed [units: participants]	58	45
Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase) [units: points on a scale] Mean ± Standard Deviation	5.4 ± 7.39	2.7 ± 7.77

No statistical analysis provided for Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)

10. Secondary:

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 ]

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11. Secondary:

Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase) [ Time Frame: Baseline and Week 26/Withdrawal ]

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12. Secondary:

Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase) [ Time Frame: Baseline and Week 16/Withdrawal ]

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13. Post-Hoc:

Number of Participants With a Withdrawal Event [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]

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14. Post-Hoc:

Number of Participants With Intervention for Any Mood Episode [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]

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15. Post-Hoc:

Number of Participants With Intervention for Depressive Episode [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]

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16. Post-Hoc:

Number of Participants With Intervention for a Manic, Hypomanic, or Mixed Episode [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

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.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00550407 History of Changes
Other Study ID Numbers:	SCA104779
Study First Received:	October 26, 2007
Results First Received:	May 24, 2010
Last Updated:	May 31, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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