Trial Outcomes & Findings for Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence (NCT NCT00563797)
NCT ID: NCT00563797
Last Updated: 2016-04-18
Results Overview
Measured with time line follow back measures
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
21 participants
Primary outcome timeframe
25 weeks
Results posted on
2016-04-18
Participant Flow
284 subjects were assessed for eligibility, but 263 were excluded because they did not meet inclusion criteria or did not want to participate.
Participant milestones
| Measure |
Mecamylamine
Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks
|
Placebo
Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
Received Allocated Intervention
|
11
|
10
|
|
Overall Study
Follow-Up
|
11
|
10
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Mecamylamine
Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks
|
Placebo
Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
2
|
Baseline Characteristics
Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Mecamylamine
n=11 Participants
Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks
|
Placebo
n=10 Participants
Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.91 years
STANDARD_DEVIATION 8.43 • n=99 Participants
|
48.20 years
STANDARD_DEVIATION 9.84 • n=107 Participants
|
49.62 years
STANDARD_DEVIATION 9.00 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 participants
n=99 Participants
|
9 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Drinks per drinking day
|
13.56 drinks per day
STANDARD_DEVIATION 8.27 • n=99 Participants
|
9.32 drinks per day
STANDARD_DEVIATION 8.99 • n=107 Participants
|
11.54 drinks per day
STANDARD_DEVIATION 8.68 • n=206 Participants
|
|
Drinking days, past 30
|
22.55 drinking days
STANDARD_DEVIATION 7.50 • n=99 Participants
|
22.10 drinking days
STANDARD_DEVIATION 8.57 • n=107 Participants
|
22.33 drinking days
STANDARD_DEVIATION 7.83 • n=206 Participants
|
|
Heavy drinking days, past 30
|
21.73 days
STANDARD_DEVIATION 7.38 • n=99 Participants
|
18.00 days
STANDARD_DEVIATION 11.62 • n=107 Participants
|
19.95 days
STANDARD_DEVIATION 9.57 • n=206 Participants
|
|
Cigarettes per day
|
13.6 cigarettes
STANDARD_DEVIATION 7.8 • n=99 Participants
|
16.6 cigarettes
STANDARD_DEVIATION 4.50 • n=107 Participants
|
14.9 cigarettes
STANDARD_DEVIATION 6.60 • n=206 Participants
|
|
Total Alcohol Dependence Scale (ADS) score
|
17.70 units on a scale
STANDARD_DEVIATION 10.34 • n=99 Participants
|
21.7 units on a scale
STANDARD_DEVIATION 9.72 • n=107 Participants
|
19.70 units on a scale
STANDARD_DEVIATION 9.98 • n=206 Participants
|
|
Depression HAMD
|
13.64 units on a scale
STANDARD_DEVIATION 5.43 • n=99 Participants
|
12.90 units on a scale
STANDARD_DEVIATION 2.93 • n=107 Participants
|
13.29 units on a scale
STANDARD_DEVIATION 4.32 • n=206 Participants
|
|
Smoking Status
Smokers
|
7 participants
n=99 Participants
|
5 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Smoking Status
Non-Smokers
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 25 weeksMeasured with time line follow back measures
Outcome measures
| Measure |
Placebo
n=10 Participants
Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill
|
Mecamylamine
n=11 Participants
Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks
|
|---|---|---|
|
Number of Drinking Days
|
17.6 days
Standard Deviation 6.570
|
12.6 days
Standard Deviation 6.570
|
PRIMARY outcome
Timeframe: 12 weeksThe Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients. Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to \>23 (Very Severe Depression)
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill
|
Mecamylamine
n=10 Participants
Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks
|
|---|---|---|
|
Depression - Measured Using the HAMD Total Score
|
8.212 units on a scale
Standard Deviation 1.592
|
8.10 units on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: 25 weeksTwo-way interaction between smoking and medication for percentage of drinking days captured by time line follow back surveys. Data are calculated as number of drinking days over the number of days in the study for smokers and nonsmokers receiving either mecamylamine or placebo.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill
|
Mecamylamine
n=10 Participants
Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks
|
|---|---|---|
|
Mean Percentage of Number of Drinking Days by Smoking Status
Smokers
|
21.34 Percentage of Drinking Days
Standard Deviation 21.96
|
4.57 Percentage of Drinking Days
Standard Deviation 6.19
|
|
Mean Percentage of Number of Drinking Days by Smoking Status
Non-Smokers
|
14.76 Percentage of Drinking Days
Standard Deviation 18.63
|
48.81 Percentage of Drinking Days
Standard Deviation 35.22
|
SECONDARY outcome
Timeframe: 25 weeksThe two-way interaction between medication by smoking status to measure percentage of heavy drinking days measured by time line follow back survey. Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) over the number of days in the study for smokers and non smokers receiving either mecamylamine or placebo.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.
Placebo: Placebo pill
|
Mecamylamine
n=10 Participants
Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks
|
|---|---|---|
|
Mean Percentage of Heavy Drinking Days by Smoking
Smokers
|
15.14 percentage of Heavy Drinking Days
Standard Deviation 19.48
|
1.68 percentage of Heavy Drinking Days
Standard Deviation 2.47
|
|
Mean Percentage of Heavy Drinking Days by Smoking
Non-Smokers
|
3.57 percentage of Heavy Drinking Days
Standard Deviation 6.19
|
31.67 percentage of Heavy Drinking Days
Standard Deviation 29.03
|
Adverse Events
Mecamylamine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mecamylamine
n=11 participants at risk
Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.
Mecamylamine: mecamylamine 10mg/day for 12 weeks
|
Placebo
n=10 participants at risk
Placebo capsules were prepared by the pharmacy and were identical in size and color to themedication capsules.
Placebo: Placebo pill
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting/Diarrhea
|
9.1%
1/11
|
0.00%
0/10
|
|
General disorders
Relapse to Drinking
|
9.1%
1/11
|
10.0%
1/10
|
|
Psychiatric disorders
Worsening of Depression
|
9.1%
1/11
|
0.00%
0/10
|
|
General disorders
Calcified Granuloma
|
0.00%
0/11
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11
|
20.0%
2/10
|
Additional Information
Elizabeth Ralevski
Yale University School Of Medicine Department of Psychiatry
Phone: 203-932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place