D-Cycloserine to Enhance Cognitive Behavioral Therapy (CBT) for Acrophobia

NCT01102803 | Completed Phase 3 Results

• 1 other identifier: KS09-81
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the utility of post-session administration of D-cycloserine to enhance fear extinction in a sample of people with acrophobia who will be treated with CBT.

Conditions

Phobic Disorders

Keywords

Phobias; Anxiety Disorders; D-Cycloserine; Phobic Disorders; Mental Disorders; Heights; Acrophobia

Outcome Measures

Primary Outcomes (1)

• Acrophobia Questionnaire With Avoidance (AAVQ)

  Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0-3) and anxiety (0-6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82-.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90.

  2 months

Secondary Outcomes (3)

• Attitudes Towards Heights Questionnaire (ATHQ)

  2 months

• Clinical Global Improvement Scale (CGI)

  2 months

• Behavioral Avoidance Test (BAT)

  2 months

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Participants will receive placebo augmented cognitive behavioral therapy

Behavioral: Individual Cognitive Behavioral Therapy (CBT); Drug: Placebo

D-Cycloserine

EXPERIMENTAL

Participants will receive D-Cycloserine augmented cognitive behavioral therapy

Behavioral: Individual Cognitive Behavioral Therapy (CBT); Drug: D-Cycloserine

Interventions

Individual Cognitive Behavioral Therapy (CBT) BEHAVIORAL

The aim of CBT is to help participants become more comfortable with heights situations. Participants will receive 2 sessions over two weeks of individual CBT.

Also known as: CBT, DCS

D-Cycloserine; Sugar Pill

D-Cycloserine DRUG

D-Cycloserine

D-Cycloserine

Placebo DRUG

Sugar Pill

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:

• Males or females 18-65 years of age with a psychiatric diagnosis of acrophobia defined by DSM-IV criteria.
• 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 and panic disorder within the past 6 months are excluded. Entry of patients with other mood or anxiety disorders will be permitted in order to increase accrual of a clinically relevant sample. Patients with significant suicidal ideation (MADRS item 10 score \> 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
• Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.
• Significant personality dysfunction likely to interfere with study participation.
• Serious medical illness or instability for which hospitalization may be likely within the next year.
• 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).
• Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of acrophobia is excluded. Prohibited psychotherapy includes CBT 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 receiving isoniazid.
• Patients unable to understand study procedures and participate in the informed consent process.

Sponsors & Collaborators

• Southern Methodist University: lead

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75206, United States

Location

Related Publications (2)

• Smits JA, Rosenfield D, Otto MW, Powers MB, Hofmann SG, Telch MJ, Pollack MH, Tart CD. D-cycloserine enhancement of fear extinction is specific to successful exposure sessions: evidence from the treatment of height phobia. Biol Psychiatry. 2013 Jun 1;73(11):1054-8. doi: 10.1016/j.biopsych.2012.12.009. Epub 2013 Jan 16.

  PMID: 23332511 DERIVED

• Tart CD, Handelsman PR, Deboer LB, Rosenfield D, Pollack MH, Hofmann SG, Powers MB, Otto MW, Smits JA. Augmentation of exposure therapy with post-session administration of D-cycloserine. J Psychiatr Res. 2013 Feb;47(2):168-74. doi: 10.1016/j.jpsychires.2012.09.024. Epub 2012 Oct 23.

  PMID: 23098672 DERIVED

MeSH Terms

Conditions

Phobic Disorders; Anxiety Disorders; Mental Disorders; Acrophobia

Interventions

Cycloserine

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Sample may not have been severe enough to see an effect of DCS; there may have been a ceiling effect; there was no pre-session pill administration; assessors were blind but not independent; only one dose of DCS was examined

Results Point of Contact

• Title: Dr. Jasper Smits
• Organization: Southern Methodist University

jsmits@smu.edu

214-768-4125

Study Officials

• Jasper Smits, Ph.D.

  Southern Methodist University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 13, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 21, 2013
• Results First Posted: February 21, 2013

Record last verified: 2012-12

Locations

US (1)