Trial Outcomes & Findings for Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression (NCT NCT00249444)

NCT ID: NCT00249444

Last Updated: 2017-10-25

Results Overview

measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 86 participants
• Primary outcome timeframe: measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation
• Results posted on: 2017-10-25

Participant Flow

There was a 2 week (no medication) lead-in period prior to randomization. To be randomized, patients had to attend at least 4 of 6 clinic visits, and submit at least 4 of 6 urine samples for toxicology during these two weeks. 86 participants were randomized.

Participant milestones

Measure	Mirtazapine Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose. Mirtazapine: Mirtazapine	Placebo placebo Placebo: placebo
Overall Study STARTED	42	44
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	12	15

Reasons for withdrawal

Measure	Mirtazapine Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose. Mirtazapine: Mirtazapine	Placebo placebo Placebo: placebo
Overall Study Lost to Follow-up	2	2
Overall Study non-compliant	9	11
Overall Study Adverse Event	1	1
Overall Study life event	0	1

Baseline Characteristics

Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression

Baseline characteristics by cohort

Measure	Mirtazapine n=42 Participants Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose. Mirtazapine: Mirtazapine	Placebo n=44 Participants placebo Placebo: placebo	Total n=86 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 7.6 • n=5 Participants	42.9 years STANDARD_DEVIATION 8.4 • n=7 Participants	42.8 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation

measured daily by self report and confimed by urine toxicology for 8 weeks of the trial or length of study participation

Outcome measures

Measure	Mirtazapine n=42 Participants Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose. Mirtazapine: Mirtazapine	Placebo n=44 Participants placebo Placebo: placebo
Cocaine Abstinence During Last Three Weeks of Study	5 participants	9 participants

PRIMARY outcome

Timeframe: End of 8 week study or last week of participation

Participants those who had a 50% decrease in HAM-D scores from baseline at end of study. The outcome measured is 50% drop in Hamilton score at week 8 or last week of study participation compared to baseline. We looked at the difference between baseline score and score at week 8 or last week of study participation.

Outcome measures

Measure	Mirtazapine n=42 Participants Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose. Mirtazapine: Mirtazapine	Placebo n=44 Participants placebo Placebo: placebo
Depression Score on Hamilton - Depression 25 Item	38 participants	42 participants

Adverse Events

Mirtazapine

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mirtazapine n=42 participants at risk Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose. Mirtazapine: Mirtazapine	Placebo n=44 participants at risk placebo Placebo: placebo
Psychiatric disorders depression	2.4% 1/42 • Number of events 1 • during 2 week lead-in and 8 weeks of trial or course of study participation	0.00% 0/44 • during 2 week lead-in and 8 weeks of trial or course of study participation
Cardiac disorders hypertension	2.4% 1/42 • Number of events 1 • during 2 week lead-in and 8 weeks of trial or course of study participation	0.00% 0/44 • during 2 week lead-in and 8 weeks of trial or course of study participation

Other adverse events

Measure	Mirtazapine n=42 participants at risk Mirtazapine will be administered on a fixed-flexible schedule, with dose titrated up to 60 mg per day or the maximum tolerated dose. Mirtazapine: Mirtazapine	Placebo n=44 participants at risk placebo Placebo: placebo
General disorders somnolence	11.9% 5/42 • Number of events 5 • during 2 week lead-in and 8 weeks of trial or course of study participation	0.00% 0/44 • during 2 week lead-in and 8 weeks of trial or course of study participation
General disorders weight gain	21.4% 9/42 • Number of events 9 • during 2 week lead-in and 8 weeks of trial or course of study participation	0.00% 0/44 • during 2 week lead-in and 8 weeks of trial or course of study participation
General disorders dizziness	4.8% 2/42 • Number of events 2 • during 2 week lead-in and 8 weeks of trial or course of study participation	2.3% 1/44 • Number of events 1 • during 2 week lead-in and 8 weeks of trial or course of study participation
General disorders restlessness	2.4% 1/42 • Number of events 1 • during 2 week lead-in and 8 weeks of trial or course of study participation	4.5% 2/44 • Number of events 2 • during 2 week lead-in and 8 weeks of trial or course of study participation
General disorders appetite increase	11.9% 5/42 • Number of events 5 • during 2 week lead-in and 8 weeks of trial or course of study participation	0.00% 0/44 • during 2 week lead-in and 8 weeks of trial or course of study participation
General disorders sweating	2.4% 1/42 • Number of events 1 • during 2 week lead-in and 8 weeks of trial or course of study participation	2.3% 1/44 • Number of events 1 • during 2 week lead-in and 8 weeks of trial or course of study participation
Cardiac disorders hypertension	2.4% 1/42 • Number of events 1 • during 2 week lead-in and 8 weeks of trial or course of study participation	0.00% 0/44 • during 2 week lead-in and 8 weeks of trial or course of study participation

Additional Information

Dr Wilfrid Raby

Columbia University

Phone: 212-923-3031

Email: rabywil@nyspi.columbia.edu

Results disclosure agreements

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