Trial Outcomes & Findings for Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism (NCT NCT00246441)

Results Overview

Liebowitz Social Anxiety Scale (LSAS) - each of the two subscales, Fear and Avoidance, each have a maximum possible score of 72 (range 0 to 72). The total score ranges from 0 to 144. A higher score indicates higher severity of Social Anxiety Disorder.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

16 weeks treatment

Results posted on

2018-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Paroxetine Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Overall Study STARTED	20	22
Overall Study COMPLETED	19	22
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paroxetine n=20 Participants Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo n=22 Participants Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.	Total n=42 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	20 Participants n=5 Participants	22 Participants n=7 Participants	42 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	28 years STANDARD_DEVIATION 6.5 • n=5 Participants	30 years STANDARD_DEVIATION 8.3 • n=7 Participants	29 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks treatment

Liebowitz Social Anxiety Scale (LSAS) - each of the two subscales, Fear and Avoidance, each have a maximum possible score of 72 (range 0 to 72). The total score ranges from 0 to 144. A higher score indicates higher severity of Social Anxiety Disorder.

Outcome measures

Outcome measures
Measure	Paroxetine n=20 Participants Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo n=22 Participants Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Social Anxiety Severity	87 units on a scale Standard Deviation 14.9	93 units on a scale Standard Deviation 18.5

PRIMARY outcome

Timeframe: 16 weeks treatment

Timeline Followback (TLFB), a validated calendar based instrument to assess number of standard drinks consumed on each day of the trial. Baseline measures were computed using past 30 days. From the TLFB, three measures were computed: 1. Proportion of days abstinent (PDA) (the number of days when no drinking occurred, divided by the number of days in the assessment period) (minimum is 0, maximum is 1) (higher score is better), 2. Drinks per drinking day (DDD) (the mean number of standard drinks consumed on a drinking day in the assessment period) (minimum is \>0, maximum is infinity) (higher score is worse), 3. Proportion of Heavy Drinking Days (PHD) (the proportion of days each assessment period that a woman consumed 4 or more standard drinks/ man consumed 5 or more standard drinks) (minimum is 0, maximum is 1) (higher score is worse).

Outcome measures

Outcome measures
Measure	Paroxetine n=20 Participants Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo n=22 Participants Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Alcohol Use, Quantity and Frequency PDA	.66 units on a scale Standard Error .07	.65 units on a scale Standard Error .07
Alcohol Use, Quantity and Frequency DDD	5.88 units on a scale Standard Error 1.02	7.00 units on a scale Standard Error 1.48
Alcohol Use, Quantity and Frequency PHD	.54 units on a scale Standard Error .11	.55 units on a scale Standard Error .13

PRIMARY outcome

Timeframe: 16 weeks treatment

Drinking days that were related to coping with Social Anxiety determined by the TLFB- the proportion of drinking days that were reported to be due to coping with social anxiety. Minimum value is 0, maximum value is 1 Higher is worse.

Outcome measures

Outcome measures
Measure	Paroxetine n=20 Participants Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo n=22 Participants Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Drinking to Cope	.35 proportion of drinking days Standard Error .1	.21 proportion of drinking days Standard Error .04

Adverse Events

Paroxetine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Paroxetine n=20 participants at risk Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day	Placebo n=22 participants at risk Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.
Reproductive system and breast disorders anorgasmia	55.0% 11/20 • 16 weeks We used a 32 item side effect checklist and we asked subjects about all items on the list at each study visit.	18.2% 4/22 • 16 weeks We used a 32 item side effect checklist and we asked subjects about all items on the list at each study visit.
Musculoskeletal and connective tissue disorders myoclonus	35.0% 7/20 • 16 weeks We used a 32 item side effect checklist and we asked subjects about all items on the list at each study visit.	4.5% 1/22 • 16 weeks We used a 32 item side effect checklist and we asked subjects about all items on the list at each study visit.
Nervous system disorders tremor	45.0% 9/20 • 16 weeks We used a 32 item side effect checklist and we asked subjects about all items on the list at each study visit.	13.6% 3/22 • 16 weeks We used a 32 item side effect checklist and we asked subjects about all items on the list at each study visit.

Additional Information

Dr. Sarah Book

MUSC

Phone: 8437925200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place