Trial Outcomes & Findings for A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency (NCT NCT01165541)

Last Updated: 2018-04-09

Results Overview

The number of "very heavy" drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

14 Weeks

Results posted on

2018-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Entire Study Population Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg) for 7 weeks.
Quetiapine XR Monotherapy STARTED	20
Quetiapine XR Monotherapy COMPLETED	16
Quetiapine XR Monotherapy NOT COMPLETED	4
Quetiapine XR and Mirtazepine STARTED	16
Quetiapine XR and Mirtazepine COMPLETED	11
Quetiapine XR and Mirtazepine NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=20 Participants Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg) for 7 weeks.
Age, Continuous	48.1 years STANDARD_DEVIATION 10.1 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 Weeks

Population: The Analysis Population only consists of participants that completed both phases of the study.

The number of "very heavy" drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week

Outcome measures

Outcome measures
Measure	Quetiapine Fumarate Extended Release (Quetiapine XR) n=11 Participants Quetiapine XR 50-400mg Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d	Quetiapine XR Plus Mirtazapine n=11 Participants Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg)
Number of Very Heavy Drinking Days Per Week	2.1 days Standard Deviation 2.8	1.3 days Standard Deviation 2.4

Adverse Events

Quetiapine Fumarate Extended Release (Quetiapine XR)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Quetiapine XR andMirtazapine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Mary Brunette, MD

Geisel School of Medicine At Dartmouth

Phone: 603-271-7642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Quetiapine Fumarate Extended Release (Quetiapine XR) n=20 participants at risk Quetiapine XR 50-400mg Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d	Quetiapine XR andMirtazapine n=16 participants at risk Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg)
Cardiac disorders Prolonged QTC	0.00% 0/20 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	6.2% 1/16 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Skin and subcutaneous tissue disorders Dermatological Condition	10.0% 2/20 • Number of events 2 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	6.2% 1/16 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Nervous system disorders Dizzy	30.0% 6/20 • Number of events 6 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	6.2% 1/16 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Psychiatric disorders Unusual Dream Activity	15.0% 3/20 • Number of events 3 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	6.2% 1/16 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Gastrointestinal disorders Dry Mouth	35.0% 7/20 • Number of events 7 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	12.5% 2/16 • Number of events 2 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
General disorders Fatigue	25.0% 5/20 • Number of events 6 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	18.8% 3/16 • Number of events 4 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
General disorders Foggy Thinking	15.0% 3/20 • Number of events 4 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	18.8% 3/16 • Number of events 4 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Gastrointestinal disorders Gastrointestinal Problems	45.0% 9/20 • Number of events 12 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	25.0% 4/16 • Number of events 7 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Nervous system disorders Headache	20.0% 4/20 • Number of events 4 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	18.8% 3/16 • Number of events 4 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Nervous system disorders Insomnia	15.0% 3/20 • Number of events 4 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	12.5% 2/16 • Number of events 3 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Psychiatric disorders Irritated	10.0% 2/20 • Number of events 2 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	6.2% 1/16 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Psychiatric disorders Miscellaneous Sleep Disorder	10.0% 2/20 • Number of events 2 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	6.2% 1/16 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Musculoskeletal and connective tissue disorders Muscoloskeletal Disorder	15.0% 3/20 • Number of events 4 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	43.8% 7/16 • Number of events 10 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Nervous system disorders Neurologic Disorder	20.0% 4/20 • Number of events 5 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	18.8% 3/16 • Number of events 3 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Respiratory, thoracic and mediastinal disorders Nose Bleeds	10.0% 2/20 • Number of events 3 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	0.00% 0/16 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Psychiatric disorders Psychiatric Symptoms	10.0% 2/20 • Number of events 4 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	12.5% 2/16 • Number of events 2 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Nervous system disorders Somnolence	40.0% 8/20 • Number of events 9 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	37.5% 6/16 • Number of events 6 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
General disorders Sweats	5.0% 1/20 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	12.5% 2/16 • Number of events 2 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Investigations Increase Triglycerides	0.00% 0/20 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	12.5% 2/16 • Number of events 2 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Symptoms	15.0% 3/20 • Number of events 6 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	0.00% 0/16 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Metabolism and nutrition disorders Weight Gain	5.0% 1/20 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	12.5% 2/16 • Number of events 2 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Eye disorders Blurred Vision	5.0% 1/20 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	0.00% 0/16 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Respiratory, thoracic and mediastinal disorders Decreased Smoking	5.0% 1/20 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	0.00% 0/16 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Psychiatric disorders Libido Descreased	5.0% 1/20 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	0.00% 0/16 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
General disorders Fever	5.0% 1/20 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	0.00% 0/16 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Metabolism and nutrition disorders Appetite Increased	5.0% 1/20 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	0.00% 0/16 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
Injury, poisoning and procedural complications Injury	10.0% 2/20 • Number of events 5 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	6.2% 1/16 • Number of events 1 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.
General disorders Swelling	5.0% 1/20 • Number of events 2 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.	0.00% 0/16 • Adverse events were collected throughout both periods of the study and included a 30 day follow-up call made after study participation ended to assess for additional events.. This study included two phases (quetiapine XR monotherapy and quetipapine XR andmirtazapine). An adverse event was attributed to a given phase if it began during that phase.