Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| KS09-088 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the utility of Yohimbine hydrochloride for facilitating fear extinction in a sample of patients with social phobia who will be treated with CBT.
The primary aim is to determine the relative efficacy of exposure-based CBT for social phobia when conducted with adjunctive acute (prior to four of five sessions) administration of either Yohimbine hydrochloride (10.8 mg) or placebo during core exposure sessions. Based on the available evidence, the investigators hypothesize that acute treatment with Yohimbine hydrochloride prior to exposure-based CBT would facilitate the extinction of fear that occurs with this treatment and would enhance treatment outcome.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Pill | Placebo Comparator | Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy |
|
| Yohimbine Hydrochloride | Experimental | Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Cognitive Behavioral Therapy | Behavioral | 5 weeks of group CBT for Social Anxiety. The aim of CBT is to help participants become more comfortable with social situations One arm will receive placebo augmented Group Cognitive Behavioral Therapy and the other will receive yohimbine hydrochloride augmented cognitive behavioral therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| The Liebowitz Social Anxiety Scale (LSAS) | 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). | LSAS means at 1 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Social Phobic Disorders Severity and Change Form | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jasper Smits, Ph.D. | Southern Methodist University | Principal Investigator |
| Michael W Otto, Ph.D. | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02215 | United States | ||
| Southern Methodist University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19223151 | Background | Powers MB, Smits JA, Otto MW, Sanders C, Emmelkamp PM. Facilitation of fear extinction in phobic participants with a novel cognitive enhancer: a randomized placebo controlled trial of yohimbine augmentation. J Anxiety Disord. 2009 Apr;23(3):350-6. doi: 10.1016/j.janxdis.2009.01.001. Epub 2009 Jan 15. | |
| 24237691 | Derived |
| Label | URL |
|---|---|
| BU Center for Anxiety and Related Disorders | View source |
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill | Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy |
| BG001 | Yohimbine Hydrochloride | Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Liebowitz Social Anxiety Scale (LSAS) | 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). | Posted | Mean | Standard Deviation | units on a scale | LSAS means at 1 month follow-up |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Pill | Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sweaty palms | General disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jasper Smits, Ph.D. | Southern Methodist University | 214-768-4310 | jsmits@smu.edu |
Not provided
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015016 | Yohimbine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Yohimbine Hydrochloride | Drug | Participants in the Yohimbine augmented arm will receive 4 doses of Yohimbine Hydrochloride before 4 of the 5 group cognitive behavioral therapy sessions. |
|
| Sugar Pill | Drug | Participants in the placebo (sugar pill) augmented arm will receive 4 doses of a sugar pill before 4 of the 5 group cognitive behavioral therapy sessions. |
|
| CGI change scores from baseline to 1 month follow-up |
| Dallas |
| Texas |
| 75206 |
| United States |
| Smits JA, Rosenfield D, Davis ML, Julian K, Handelsman PR, Otto MW, Tuerk P, Shiekh M, Rosenfield B, Hofmann SG, Powers MB. Yohimbine enhancement of exposure therapy for social anxiety disorder: a randomized controlled trial. Biol Psychiatry. 2014 Jun 1;75(11):840-6. doi: 10.1016/j.biopsych.2013.10.008. Epub 2013 Oct 16. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Social Phobic Disorders Severity and Change Form | 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. | Posted | Mean | Standard Deviation | units on a scale | CGI change scores from baseline to 1 month follow-up |
|
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | Yohimbine Hydrochloride | Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy | 0 | 20 | 19 | 20 |
| Headache | General disorders |
|
| Decrease in sexual arousal | General disorders |
|
| Insomnia | General disorders |
|
| Crying | General disorders |
|
| Jittery/Jumpy | General disorders |
|
| Tiredness | General disorders |
|
| Light-headedness | General disorders |
|
| Sweating | General disorders |
|
| Alertness | General disorders |
|
| Dazed | General disorders |
|
| Heart palpitations | General disorders |
|
| Hunger | General disorders |
|
| Anxiety | General disorders |
|
| Open sinuses | General disorders |
|
| Hot flash/chills | General disorders |
|
| Nausea | General disorders |
|
| Pressure around the eyes | General disorders |
|
Not provided
Not provided
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D002241 | Carbohydrates |