Trial Outcomes & Findings for Lamotrigine for Symptoms of Geriatric Bipolar Depression (NCT NCT00621842)

NCT ID: NCT00621842

Last Updated: 2014-12-30

Results Overview

The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 57 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-12-30

Participant Flow

Recruitment began in January 2008 and ended in December 2009. The study screened and enrolled participants at five academic institutions in the United States.

All subjects were required to have a score of 18 or higher on the Hamilton Rating Scale for Depression 24 to be included in the study.

Participant milestones

Measure	Open-label Lamotrigine Treatment This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Study STARTED	57
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	Open-label Lamotrigine Treatment This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Study Adverse Event	6
Overall Study Withdrawal by Subject	7
Overall Study Protocol Violation	4
Overall Study Lack of Efficacy	2

Baseline Characteristics

Lamotrigine for Symptoms of Geriatric Bipolar Depression

Baseline characteristics by cohort

Measure	Open-label Lamotrigine Treatment n=57 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants
Age, Continuous	66.5 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.

The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=54 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)	-15.5 units on a scale Interval -18.0 to -12.9

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants was chosen from the number who received at least one dose of lamotrigine.

Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=57 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) reduced sleep duration	14 participants
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) weight loss	12 participants
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) increased dream activity	12 participants
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) polyuria/polydipsia	11 participants
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) weight gain	9 participants
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) increased sleep	9 participants
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) lassitude/fatigue	8 participants
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) unsteady gait	8 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.

The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=54 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)	-15.2 units on a scale Interval -17.5 to -12.9

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.

The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=49 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)	-.47 units on a scale Interval -1.82 to 0.88

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.

The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=53 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP	-2.06 units on a scale Interval -2.43 to -1.68

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.

The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=48 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)	-.04 units on a scale Interval -0.36 to 0.28

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=52 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Change in Body Weight From Baseline	.83 lbs. Interval -0.97 to 2.62

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants was chosen from the number who received at least one dose of lamotrigine.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=57 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Number of Participants Who Fell at Least Once During the Study	18 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.

The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=48 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)	-.79 units on a scale Interval -1.67 to 0.09

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.

The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=47 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)	-.53 units on a scale Interval -1.03 to -0.04

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants was chosen from the number who received at least one dose of lamotrigine.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=57 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Number of Participants Who Had a Fall That Required Medical Attention	5 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants was chosen from the number who received at least one dose of lamotrigine.

Outcome measures

Measure	Open-label Lamotrigine Treatment n=57 Participants This solitary group received open-label lamotrigine treatment for bipolar depression.
Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine	1 participants

Adverse Events

Open-label Lamotrigine Treatment

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Open-label Lamotrigine Treatment n=57 participants at risk This solitary group received open-label lamotrigine treatment for bipolar depression.
Psychiatric disorders Hospital Admission for Increased Anxiety	1.8% 1/57 • Number of events 1 • Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.
Renal and urinary disorders Hospital Admission for Urinary Tract Infection	1.8% 1/57 • Number of events 1 • Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.

Other adverse events

Measure	Open-label Lamotrigine Treatment n=57 participants at risk This solitary group received open-label lamotrigine treatment for bipolar depression.
Metabolism and nutrition disorders Weight gain	7.0% 4/57 • Number of events 4 • Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.
Metabolism and nutrition disorders Weight Loss	7.0% 4/57 • Number of events 6 • Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.
Skin and subcutaneous tissue disorders Rash	7.0% 4/57 • Number of events 4 • Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.
Renal and urinary disorders Increased Urinary Frequency	5.3% 3/57 • Number of events 4 • Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.
Injury, poisoning and procedural complications Fall	31.6% 18/57 • Number of events 28 • Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.
Gastrointestinal disorders Vomiting	7.0% 4/57 • Number of events 9 • Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.

Additional Information

Christopher Bialko

Case Western Reserve University

Phone: 216-286-4362

Email: Christopher.Bialko@UHhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60