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

NCT00958880 | Completed Phase 3 Results

• 1 other identifier: KS09-088
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Social Phobic Disorders Severity and Change Form

  CGI change scores from baseline to 1 month follow-up

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy

Behavioral: Group Cognitive Behavioral Therapy; Drug: Sugar Pill

Yohimbine Hydrochloride

EXPERIMENTAL

Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy

Behavioral: Group Cognitive Behavioral Therapy; Drug: Yohimbine Hydrochloride

Interventions

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.

Sugar Pill; Yohimbine Hydrochloride

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.

Yohimbine Hydrochloride

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.

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients between 18 and 65 years of age with a primary psychiatric diagnosis (designated by the patient as the most important source of current distress) of non-generalized social anxiety disorder (SAD) or Generalized Social Anxiety Disorder (GSAD) with a significant fear of public speaking as defined by DSM-IV criteria.
• Severity of the social phobia of at least 3 on the CGI scale rated for the severity of public speaking anxiety
• Willingness and ability to comply with the requirements of the study protocol.

You may not qualify if:

• A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance (amphetamines, benzodiazepines, barbiturates, cocaine metabolites, marijuana, narcotics, and sedative hypnotics) abuse or dependence or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
• Patients with posttraumatic stress disorder within the past 6 months are excluded. Entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample. Patients with significant suicidal ideation (BDI item 9 score \> 1) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
• Given that Yohimbine hydrochloride is frequently used as an adjunctive medication in order to decrease side effects commonly resulting from antidepressant use (Pollack \& Smoller, 1996), antidepressant and anxiolytic medications are acceptable if they are stabilized for at least 8 weeks prior to the baseline assessments. However, individuals taking monoamine oxidase inhibitors or tricyclic antidepressants will be excluded from the study unless they are able and willing to discontinue these medications prior to baseline screening.
• Individuals taking antihistamines or strattera (atomoxetine) will be excluded from the study unless they are able and willing to discontinue these medications prior to baseline screening
• Evidence through interview or physical exam of significant general medical condition (e.g renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy) that may interfere with the interpretation of safety and efficacy evaluations in the opinion of the prescribing physician.
• Resting blood pressure ≥ 160 systolic and/or 100 diastolic. Individuals currently being treated for high blood pressure and meeting these criteria are eligible.
• Significant personality dysfunction likely to interfere with study participation.
• Patients with a current or past history of seizures
• Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months). A urine pregnancy test will be performed on all female subjects of child-bearing potential at the screening visit.
• Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the SAD is excluded. Prohibited psychotherapy includes CBT or psychodynamic therapy focusing on exploring specific, dynamic causes of the phobic symptomatology and provides management skills. General supportive therapy initiated \> 3 months prior is acceptable.
• Prior non-response to adequately-delivered exposure (i.e., as defined by the patient's report of receiving specific and regular exposure assignments as part of a previous treatment) will exclude participants from the study.
• Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
• Patients unable to understand study procedures and participate in the informed consent process.

Sponsors & Collaborators

• Southern Methodist University: lead

Study Sites (2)

Boston University

Boston, Massachusetts, 02215, United States

Location

Southern Methodist University

Dallas, Texas, 75206, United States

Location

Related Publications (2)

• 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.

  PMID: 19223151 BACKGROUND

• 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.

  PMID: 24237691 DERIVED

Related Links

• BU Center for Anxiety and Related Disorders

MeSH Terms

Conditions

Phobia, Social

Interventions

Yohimbine; Sugars

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Carbohydrates

Results Point of Contact

• Title: Jasper Smits, Ph.D.
• Organization: Southern Methodist University

jsmits@smu.edu

214-768-4310

Study Officials

• Jasper Smits, Ph.D.

  Southern Methodist University

  PRINCIPAL INVESTIGATOR

• Michael W Otto, Ph.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 11, 2013
• Results First Posted: November 11, 2013

Record last verified: 2013-09

Locations

US (2)