Trial Outcomes & Findings for Yohimbine to Enhance Cognitive Behavioral Therapy (CBT) for Social Anxiety (NCT NCT00958880)

Last Updated: 2013-11-11

Results Overview

The Liebowitz Social Anxiety Scale (LSAS) is a self-report measure of social anxiety symptom severity. Scores range from 0 to 144, with higher scores indicating more social anxiety symptoms severity (i.e., a worse outcome).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

LSAS means at 1 month follow-up

Results posted on

2013-11-11

Participant Flow

Participants were screened for eligibility criteria using an online screen. Potentially eligible participants were invited to the laboratory for a psychiatric interview. Eligible participants were enrolled in the Dallas area from 2009 to 2012.

Participants were not enrolled if they did not meet the study inclusion criteria at a psychiatric screening or medical evaluation designed to rule out contraindicated psychiatric or medical conditions.

Participant milestones

Participant milestones
Measure	Sugar Pill Participants received placebo (sugar pill) augmented Group Cognitive Behavioral Therapy. The pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.	Yohimbine Hydrochloride Participants received Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy. Participants received Yohimbine HCL augmented Group Cognitive Behavioral Therapy. The 10.8 mg pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
Overall Study STARTED	20	20
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sugar Pill Participants received placebo (sugar pill) augmented Group Cognitive Behavioral Therapy. The pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.	Yohimbine Hydrochloride Participants received Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy. Participants received Yohimbine HCL augmented Group Cognitive Behavioral Therapy. The 10.8 mg pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Yohimbine to Enhance Cognitive Behavioral Therapy (CBT) for Social Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Pill n=20 Participants Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy	Yohimbine Hydrochloride n=20 Participants Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy	Total n=40 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	20 Participants n=7 Participants	40 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	38.70 years STANDARD_DEVIATION 12.08 • n=5 Participants	35.50 years STANDARD_DEVIATION 14.02 • n=7 Participants	36.13 years STANDARD_DEVIATION 12.83 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: LSAS means at 1 month follow-up

Outcome measures

Outcome measures
Measure	Sugar Pill n=20 Participants Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy	Yohimbine Hydrochloride n=20 Participants Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
The Liebowitz Social Anxiety Scale (LSAS)	41.0 units on a scale Standard Deviation 22.0	33.3 units on a scale Standard Deviation 17.5

SECONDARY outcome

Timeframe: CGI change scores from baseline to 1 month follow-up

Social Phobic Disorders Severity and Change (SPDSC) Form is a version of the Clinical Global Improvement-Severity scale adapted specifically for clinician ratings of social anxiety disorder symptom severity. The scale ranges from 0 to 5, with higher scores indicating more social anxiety symptoms severity (i.e., worse outcomes). We examined the change in SPDSC scores from baseline to a 1 month follow-up.

Outcome measures

Outcome measures
Measure	Sugar Pill n=20 Participants Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy	Yohimbine Hydrochloride n=20 Participants Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
Social Phobic Disorders Severity and Change Form	2.0 units on a scale Standard Deviation 0.9	2.0 units on a scale Standard Deviation 0.8

Adverse Events

Sugar Pill

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Yohimbine Hydrochloride

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sugar Pill n=20 participants at risk Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy	Yohimbine Hydrochloride n=20 participants at risk Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
General disorders Sweaty palms	5.0% 1/20 • Number of events 1	0.00% 0/20
General disorders Headache	15.0% 3/20 • Number of events 3	10.0% 2/20 • Number of events 2
General disorders Decrease in sexual arousal	5.0% 1/20 • Number of events 1	0.00% 0/20
General disorders Insomnia	0.00% 0/20	10.0% 2/20 • Number of events 2
General disorders Crying	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Jittery/Jumpy	0.00% 0/20	10.0% 2/20 • Number of events 2
General disorders Tiredness	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Light-headedness	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Sweating	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Alertness	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Dazed	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Heart palpitations	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Hunger	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Anxiety	0.00% 0/20	10.0% 2/20 • Number of events 2
General disorders Open sinuses	0.00% 0/20	5.0% 1/20 • Number of events 1
General disorders Hot flash/chills	0.00% 0/20	30.0% 6/20 • Number of events 6
General disorders Nausea	0.00% 0/20	15.0% 3/20 • Number of events 3
General disorders Pressure around the eyes	0.00% 0/20	5.0% 1/20 • Number of events 1

Additional Information

Jasper Smits, Ph.D.

Southern Methodist University

Phone: 214-768-4310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place