Trial · NCT01602510
Lamotrigine Phase III Study in Bipolar I Disorder
NCT01602510, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lamotrigine Phase III Study in Bipolar I Disorder. Trials, record NCT01602510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01602510
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lamotrigine Phase III Study in Bipolar I Disorder
- NCT number
- NCT01602510
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 265 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Bipolar Disorder
- Interventions
- Lamotrigine, Placebo
- First posted
- 2012-05-21
- Last updated
- 2017-01-23
- Results first posted
- 2017-01-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Intervention for Any Mood Episode (TIME) | 36 weeks (wks) | TIME is defined as being the time from entry into the randomized double-blind 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 and/or recurrence of a depressive, manic, hypomanic or mixed episode, whichever occurs first. TIME was measured relative to randomization date. Par. prematurely discontinued from the study prior to reaching the TIME event were censored at the time of discontinuation. Analysis was performed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. |
| Secondary | Time to Intervention for Manic, Hypomanic or Mixed Episode (TIMan) | 36 weeks | TIMan was analyzed using using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation. |
| Secondary | Time to Intervention for Depressive Episode (TIDep) | 36 weeks | TIDep was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation. |
| Secondary | Overall Survival in Study (TIME-SIS). | 36 weeks | TIME-SIS was defined as the time to intervention (addition of pharmacotherapy or ECT) for any mood episode, or to the time when the participant is withdrawn for any reason after randomization. The premature discontinuation of a participant prior to reaching TIME, for any reason, was treated as an event related to bipolar disorder. All participants prematurely discontinued prior to the TIME event in this analysis were to be assumed to have reached TIME. TIMS-SIS was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation. |
| Secondary | Change From Baseline in Clinical Global Impression of Improvements (CGI-I) | Baseline and up to 36 weeks | The CGI-I is a 7-point scale where investigator were asked to assess the participant's illness at the time of assessment (improved or worsened) relative to a baseline state. In this scale, 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; or 7= very much worse. Analysis was performed using Analysis of covariance with covariates of site, CGI-S baseline score and treatment. In presented Last-observation-carried-forward datasets, the last non-missing on therapy (OT) score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. Baseline value was defined as the last non-missing values at or prior to the randomization. Change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either baseline or post-baseline value was missing, the change from baseline was set to missing. |
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) | Baseline and up to 36 weeks | The CGI-S is a 7-point scale where investigator were asked to rate the severity of the participant's illness at the time of assessment on severity of mental illness, where 1= normal, and 7= extremely ill. Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32 and 36. Analysis performed using Analysis of Covariance (ANCOVA) with covariates of site, CGI-S baseline score (Open label phase), treatment and CGI-S baseline score. In presented Last observation carried forward (LOCF) datasets, last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for remaining study visits of treatment period. The baseline value was defined as last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well. |
| Secondary | Change From Baseline in Hamilton Depression Rating Scale (HAMD) | Baseline and up to 36 weeks | HAMD consists of 17 items: depressed mood, feelings of guilt, suicide, insomnia-early, middle, late, work and activities, retardation, agitation, anxiety psychic, anxiety somatic, somatic symptoms gastro-intestinal, general somatic symptoms, hypochondriasis, loss of weight, and insight. Investigators rated par. from 0 to 4 (or 2) for these items. Total score is sum of all subscales (0 to 52, higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline (BL) score, treatment and HAMD total BL score. The last non-missing OT score prior to TIME was carried forward to estimate missing data points for remaining study visits of the treatment period. BL value was defined as the last non-missing value at or prior to the randomization. Change from BL was calculated by subtracting BL from the specific post-BL value. If BL or post-BL value was missing, the change from BL was set to missing. |
| Secondary | Change From Baseline in Young Mania Rating Scale (YMRS) Total Score | Baseline and up to 36 weeks | YMRS consists of 11 items: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech, Language/Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance, and Insight. Investigators rated par. from 0 to 4 (or 8) for each of these items. Total score is the sum of all subscales, from 0 to 60 (higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and YMRS total BL score. In LOCF datasets, the last non-missing OT score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. BL value was defined as the last non-missing values at or prior to the randomization. Change from BL at the time point of interest was calculated by subtracting BL value from the individual post-BL value. If either the BL or post-BL value was missing, change from BL was set to missing. |
| Secondary | Change From Baseline of Global Assessment Scale (GAS) Total Score | Baseline and up to 36 weeks | For GAS, investigators rated par. for lowest level of functioning during the previous week. The scale has a 10 score categories: 1-10, 11-20, 21-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, 91-100, using intermediary levels when appropriate (from 100 to 1, Lower is worse.). Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and GAS total BL score. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The BL value was defined as the last non-missing values at or prior to the randomization. The change from BL at the time point of interest was calculated by subtracting the BL values from the individual post-BL values. If either the BL or post-BL value was missing, the change from BL was set to missing as well. |
| Secondary | Change From Baseline in Body Weight | Baseline and up to 36 weeks. | Participant's body weight was measured on Weeks 0, 4, 8, 12, 16, 20, 24, 32 and 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline score, treatment and baseline body weight. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The baseline value was defined as the last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Intervention for Any Mood Episode (TIME) | 36 weeks (wks) | Randomized (RD) Full analysis population: comprised of all randomized par. who took at least one dose of study medication and had at least one post-baseline efficacy/health outcomes assessment during randomized double-blind phase. NA implies no data are available. Only those par. with available data at indicated time points were analyzed. | Days | MEDIAN |
| SECONDARY | Time to Intervention for Manic, Hypomanic or Mixed Episode (TIMan) | 36 weeks | RD Full Analysis Population.NA implies no data are available. Only those par. with available data at indicated time points were analyzed. | Days | MEDIAN |
| SECONDARY | Time to Intervention for Depressive Episode (TIDep) | 36 weeks | RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed. | Days | MEDIAN |
| SECONDARY | Overall Survival in Study (TIME-SIS). | 36 weeks | RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Improvements (CGI-I) | Baseline and up to 36 weeks | RD Full Analysis Population. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity (CGI-S) | Baseline and up to 36 weeks | RD Full Analysis Population. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hamilton Depression Rating Scale (HAMD) | Baseline and up to 36 weeks | RD Full Analysis Population | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Young Mania Rating Scale (YMRS) Total Score | Baseline and up to 36 weeks | RD Full Analysis Population | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline of Global Assessment Scale (GAS) Total Score | Baseline and up to 36 weeks | RD Full Analysis Population | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight | Baseline and up to 36 weeks. | RD Full Analysis Population. Only those par. with available data at indicated time points were analyzed. | Kilograms | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Intervention for Any Mood Episode (TIME) | Randomized Placebo | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Intervention for Any Mood Episode (TIME) | Randomized Lamotrigine 200 mg/Day | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Intervention for Manic, Hypomanic or Mixed Episode (TIMan) | Randomized Placebo | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Intervention for Manic, Hypomanic or Mixed Episode (TIMan) | Randomized Lamotrigine 200 mg/Day | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Intervention for Depressive Episode (TIDep) | Randomized Placebo | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Intervention for Depressive Episode (TIDep) | Randomized Lamotrigine 200 mg/Day | NA | 95% Confidence Interval NA to NA | Days | |
| Overall Survival in Study (TIME-SIS). | Randomized Placebo | 183 | 95% Confidence Interval 140 to NA | Days | |
| Overall Survival in Study (TIME-SIS). | Randomized Lamotrigine 200 mg/Day | 188 | 95% Confidence Interval 117 to NA | Days | |
| Change From Baseline in Clinical Global Impression of Improvements (CGI-I) | Randomized Placebo | 2.6 | Standard Error 0.20 | Score on a scale | |
| Change From Baseline in Clinical Global Impression of Improvements (CGI-I) | Randomized Lamotrigine 200 mg/Day | 2.7 | Standard Error 0.21 | Score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open Label Phase | STARTED | Open Label Lamotrigine 200 mg/Day | 420 | |
| Open Label Phase | STARTED | Randomized Placebo | 0 | |
| Open Label Phase | STARTED | Randomized Lamotrigine 200 mg/Day | 0 | |
| Open Label Phase | COMPLETED | Open Label Lamotrigine 200 mg/Day | 117 | |
| Open Label Phase | COMPLETED | Randomized Placebo | 0 | |
| Open Label Phase | COMPLETED | Randomized Lamotrigine 200 mg/Day | 0 | |
| Open Label Phase | NOT COMPLETED | Open Label Lamotrigine 200 mg/Day | 303 | |
| Open Label Phase | NOT COMPLETED | Randomized Placebo | 0 | |
| Open Label Phase | NOT COMPLETED | Randomized Lamotrigine 200 mg/Day | 0 | |
| Randomized Phase | STARTED | Open Label Lamotrigine 200 mg/Day | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events184
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Randomized Placebo | 4 | 133 | |
| other | Nasopharyngitis | Infections and infestations | Randomized Lamotrigine 200 mg/Day | 4 | 131 | |
| other | Urinary tract infection | Infections and infestations | Randomized Placebo | 4 | 133 | |
| other | Urinary tract infection | Infections and infestations | Randomized Lamotrigine 200 mg/Day | 3 | 131 | |
| other | Upper respiratory tract infection | Infections and infestations | Randomized Placebo | 4 | 133 | |
| other | Upper respiratory tract infection | Infections and infestations | Randomized Lamotrigine 200 mg/Day | 2 | 131 | |
| other | Herpes zoster | Infections and infestations | Randomized Placebo | 0 | 133 | |
| other | Herpes zoster | Infections and infestations | Randomized Lamotrigine 200 mg/Day | 1 | 131 | |
| other | Pericoronitis | Infections and infestations | Randomized Placebo | 1 | 133 | |
| other | Pericoronitis | Infections and infestations | Randomized Lamotrigine 200 mg/Day | 0 | 131 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomized Placebo | ||
| Total, all-cause mortality | Randomized Lamotrigine 200 mg/Day | ||
| Total, other adverse events | Randomized Placebo | 46 | 133 |
| Total, other adverse events | Randomized Lamotrigine 200 mg/Day | 40 | 131 |
| Total, serious adverse events | Randomized Placebo | 3 | 133 |
| Total, serious adverse events | Randomized Lamotrigine 200 mg/Day | 2 | 131 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35909213 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Randomized Lamotrigine 200 mg/Day vs Randomized Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01602510
GET https://conductscience.org/api/trials/v1/NCT01602510/events?page=2