Trial Outcomes & Findings for Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects (NCT NCT00322309)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Week 11

Results posted on

2017-04-20

Participant Flow

Subjects were recruited at the Boston University Psychiatry Associates Clinical Studies Unit

Participant milestones

Participant milestones
Measure	Mirtazapine Mirtazapine daily: Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg	Placebo Matched placebo given daily days 1-84
Overall Study STARTED	11	13
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirtazapine n=11 Participants Mirtazapine daily: Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg	Placebo n=13 Participants Subjects received matched placebo capsules	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 5.6 • n=5 Participants	47.2 years STANDARD_DEVIATION 6.7 • n=7 Participants	45.7 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
Ln Urine Benzoylecgonine Conc	9.3 ln (ng/ml) STANDARD_DEVIATION 1.7 • n=5 Participants	9.1 ln (ng/ml) STANDARD_DEVIATION 2.4 • n=7 Participants	9.2 ln (ng/ml) STANDARD_DEVIATION 2.1 • n=5 Participants

PRIMARY outcome

Timeframe: Week 11

Population: Data was analyzed for all subjects who provided data for the second assessment visit.

Outcome measures

Outcome measures
Measure	Mirtazapine n=11 Participants Mirtazapine daily: Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg	Placebo n=13 Participants Subjects received matched placebo capsules
Ln Benzoylecgonine Concentration	9.8 ln (ng/ml) Standard Deviation 1.8	7.9 ln (ng/ml) Standard Deviation 3.2

SECONDARY outcome

Timeframe: Week 11

Population: Data was analyzed fof all subjects for whom data from the second evaluation visit was available

Clinician's overall assessment of the subjects global functioning including the severity of the subject's cocaine use, cocaine seeking, use of other drugs, psychiatric symptoms, medical problems, maladaptive family/social coping, and coping with issues related to employment, housing, and legal issues. Totals range between 7 (for none) to 56 for most severe.

Outcome measures

Outcome measures
Measure	Mirtazapine n=11 Participants Mirtazapine daily: Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg	Placebo n=13 Participants Subjects received matched placebo capsules
The Clinical Global Impression Observer (CGI-O)Comparison for Week 11	29.9 Scores on a scale Standard Deviation 4.8	23.1 Scores on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Week 11

Subjects are assessed on 24 characteristics of depressive disorders. Scale scores may range from 0 for no depressive symptoms to 75.

Outcome measures

Outcome measures
Measure	Mirtazapine n=11 Participants Mirtazapine daily: Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg	Placebo n=13 Participants Subjects received matched placebo capsules
Hamilton Depression Rating Scale	7.2 Scores on a scale Standard Deviation 4.7	6.7 Scores on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Weeks 1 to 11

Percentage of medication capsules administered based on the ratio of the number of capsules administered to the total number dispensed for entire period during which subjects were in treatment.

Outcome measures

Outcome measures
Measure	Mirtazapine n=11 Participants Mirtazapine daily: Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg	Placebo n=13 Participants Subjects received matched placebo capsules
Pill Count	91 Percentage of dispensed capsules Standard Deviation 21	91 Percentage of dispensed capsules Standard Deviation 15

SECONDARY outcome

Timeframe: Weeks 1-11

This measure of adherence was determined by finding the percent of total urines examined that were positive for riboflavin, which had been added to each medication tablet.

Outcome measures

Outcome measures
Measure	Mirtazapine n=11 Participants Mirtazapine daily: Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg	Placebo n=13 Participants Subjects received matched placebo capsules
Percent Urines Positive for Riboflavin	93.5 Percentage of total urines examined Standard Deviation 7.6	93.5 Percentage of total urines examined Standard Deviation 9.5

Adverse Events

Mirtazapine Daily: Days 1-4 15mg Days 5-9 30mg Mirtazapine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mirtazapine Daily: Days 1-4 15mg Days 5-9 30mg Mirtazapine n=11 participants at risk Mirtazapine daily: Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg	Placebo n=13 participants at risk Matched placebo
Nervous system disorders Sleepiness	18.2% 2/11 • Number of events 2	0.00% 0/13
Psychiatric disorders Depression	0.00% 0/11	7.7% 1/13 • Number of events 1
Psychiatric disorders Mood Swings	9.1% 1/11 • Number of events 1	0.00% 0/13
Psychiatric disorders Agitation	9.1% 1/11 • Number of events 1	0.00% 0/13
Nervous system disorders Fainting	9.1% 1/11 • Number of events 1	0.00% 0/13

Additional Information

Maryam Afshar, MD

BUPA CSU, Boston University School of Medicine

Phone: 617-414-1990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place