Trial Outcomes & Findings for Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study) (NCT NCT02816138)
NCT ID: NCT02816138
Last Updated: 2018-09-27
Results Overview
Primary mood outcome measured by the total score of the clinician-rated MADRS. MADRS was measured every 3 weeks (baseline, week 3, week 6, week 9, and week 12). MADRS total score range is 0-60, where higher scores indicate greater depression severity.
COMPLETED
PHASE4
15 participants
Baseline to week 12
2018-09-27
Participant Flow
Participant milestones
| Measure |
Transdermal Nicotine Patch
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Transdermal Nicotine Patch
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)
Baseline characteristics by cohort
| Measure |
Transdermal Nicotine Patch
n=15 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
|
Past smoker (defined as smoking at least 1 cigarette daily for at least 6 months over the lifetime)
|
5 Participants
n=5 Participants
|
|
Depression severity (measured by Montgomery Asberg Depression Rating Scale total score)
|
27.7 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: Analyses included all participants, including the one subject who withdrew early. Missing values were imputed using the mean value of the sample at that time point.
Primary mood outcome measured by the total score of the clinician-rated MADRS. MADRS was measured every 3 weeks (baseline, week 3, week 6, week 9, and week 12). MADRS total score range is 0-60, where higher scores indicate greater depression severity.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=15 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in Total MADRS (Montgomery Asberg Depression Rating Scale) Score
|
-18.45 units on a scale
Standard Deviation 7.98
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: Subject who withdrew early not included due to no 12-week data.
Primary cognitive outcome, the CPT is a neuropsychological test that measures attention. In this 14-minute test, participants are asked to respond when any letter appears, except the non-target letter "X". This test is conducted at baseline and at week 12. The specific primary outcome metric is standard error of change in the inter-stimulus hit reaction time, or variability between different trials. There is no absolute range, but lower scores indicate decreased variability across trials and overall better performance.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=14 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in Continuous Performance Task (CPT) Performance
|
-0.003 milliseconds
Standard Deviation 0.135
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: One subject not included due to early withdrawal
Secondary mood outcome: Change in anhedonia measured by SHAPS, a self-report questionnaire that ranges from 0-42, where higher scores indicate greater anhedonia.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=14 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
|
-3.4 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: One participant not included due to early withdrawal.
Secondary mood outcome: Change in anxiety and worry measured by PSWQ, a self-report questionnaire with a range of 16-80, where higher scores indicate greater anxiety and worry.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=14 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in Penn State Worry Questionnaire (PSWQ)
|
-5.1 units on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Subject who withdrew early not included due to no 12-week data.
Secondary mood outcome: Change in rumination measured by the Ruminative Response Scale total score measured at baseline and week 12. This is a self-report scale with a range of 0-66, where higher scores indicate higher levels of rumination.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=14 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in Ruminative Response Scale Total Score
|
-9.0 units on a scale
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Subject who withdrew early not included due to no 12-week data.
Secondary Mood Outcomes: Change in apathy as measured by the self-report AES, a questionnaire with a range of 0-54, where lower scores indicate greater apathy.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=14 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in Apathy Evaluation Scale (AES)
|
7.7 units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Subject who withdrew early not included due to no 12-week data.
Secondary cognitive outcome: Change in subjective cognitive performance as measured by MFQ, a self-report scale ranging from 64-448. Higher scores indicate better subjective memory function, while lower scores indicate poorer subjective memory function.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=14 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in MFQ (Memory Frequency Questionnaire) Score
|
23.64 units on a scale
Standard Deviation 40.96
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Subject who withdrew early not included due to no 12-week data.
Secondary cognitive outcome, a neuropsychological test measure of attention. We examined the total response time for the CRT. Lower scores indicate better performance.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=14 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in Choice Reaction Time (CRT) Performance
|
-16.0 milliseconds
Standard Error 85.9
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Subject who withdrew early not included due to no 12-week data.
Secondary cognitive outcome examining change in speed of responses ton the one-back test, no absolute range. In this variant of the "N-back" task, participants view a series of cards, and indicate whether the card they are currently viewing is identical to the previously viewed card. Lower scores indicate better performance.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=14 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in One-back Test Performance
|
-0.040 milliseconds
Standard Deviation 0.065
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Subject who withdrew early not included due to no 12-week data.
Secondary cognitive outcome of a neuropsychological test examining episodic memory performance using the NYU Paragraph Recall test. No absolute range. Higher scores indicate better performance.
Outcome measures
| Measure |
Transdermal Nicotine Patch
n=14 Participants
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Change in NYU (New York University) Paragraph Recall Performance
|
3.4 Items correct
Standard Error 5.8
|
Adverse Events
Transdermal Nicotine Patch
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transdermal Nicotine Patch
n=15 participants at risk
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing began at 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily. Dose could be reduced to the prior level or an intermediate level for tolerability.
Titration schedule: 3.5mg patch x 1 week, 7mg patch x 2 weeks, 14mg patch x 3 weeks, 21mg patch x 6 weeks.
Nicotine: Open-label transdermal nicotine patch
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
46.7%
7/15 • 12 weeks
Adverse events collected through query of subjects about any new or worsening problems or side effects, conducted at each contact.
|
|
Nervous system disorders
Dizziness
|
26.7%
4/15 • 12 weeks
Adverse events collected through query of subjects about any new or worsening problems or side effects, conducted at each contact.
|
|
Psychiatric disorders
Anxiety
|
20.0%
3/15 • 12 weeks
Adverse events collected through query of subjects about any new or worsening problems or side effects, conducted at each contact.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • 12 weeks
Adverse events collected through query of subjects about any new or worsening problems or side effects, conducted at each contact.
|
|
Nervous system disorders
Vivid Dreams
|
20.0%
3/15 • 12 weeks
Adverse events collected through query of subjects about any new or worsening problems or side effects, conducted at each contact.
|
|
Skin and subcutaneous tissue disorders
Patch site reaction
|
20.0%
3/15 • 12 weeks
Adverse events collected through query of subjects about any new or worsening problems or side effects, conducted at each contact.
|
Additional Information
Warren D. Taylor, MD
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place