Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01102803
Other study ID # KS09-81
Secondary ID
Status Completed
Phase Phase 3
First received April 9, 2010
Last updated January 18, 2013
Start date April 2010
Est. completion date July 2011

Study information

Verified date December 2012
Source Southern Methodist University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Males or females 18-65 years of age with a psychiatric diagnosis of acrophobia defined by DSM-IV criteria.

2. Willingness and ability to comply with the requirements of the study protocol.

Exclusion Criteria:

1. 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.

2. 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.

3. Patients must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.

4. Significant personality dysfunction likely to interfere with study participation.

5. Serious medical illness or instability for which hospitalization may be likely within the next year.

6. Patients with a current or past history of seizures.

7. 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).

8. 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.

9. 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.

10. Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.

11. Patients receiving isoniazid.

12. Patients unable to understand study procedures and participate in the informed consent process.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Individual Cognitive Behavioral Therapy (CBT)
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.
Drug:
D-Cycloserine
D-Cycloserine
Placebo
Sugar Pill

Locations

Country Name City State
United States Southern Methodist University Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Attitudes Towards Heights Questionnaire (ATHQ) Self-report measures that assesses thoughts and feelings towards heights situations. This questionnaire (Abelson and Curtis, 1989) includes six heights situations and assesses attitudes toward these situations using a 0-10 scale. Higher scores indicate a worse outcome and total scores are summed over subscales. Will be assessed at each visit throughout the 2 month protocol. The minimum score is a 0; the maximum is a 60. 2 months No
Secondary Clinical Global Improvement Scale (CGI) Clinician-rated measure of improvement in acrophobia symptoms and severity. Will be assessed at each visit throughout the 2 month protocol. The CGI-S and CGI-I are widely used measures of global psychopathology severity and improvement initially developed for the study of psychotropic drugs (Guy, 1970). In order to obtain CGI ratings, the therapists (blind to study condition) interviewed the participant and used the SCID (including the specific phobia module) as well as the additional measures of acrophobia symptoms (BAT, AAQ, AAVQ, and ATHQ). In the current study, response was defined as either "very much improved" or "much improved" on CGI-I (score = 2). Remission was defined as either "normal" or "minimally ill" on CGI-S (score = 2). The minimum rating is a 1 and the highest is a 7. Lower scores indicate a better outcome. 2 months No
Secondary Behavioral Avoidance Test (BAT) During the initial screen, at post-treatment, and at follow-up, participants underwent a behavioral avoidance test in the virtual reality height environment. Participants reported on a 0-100 scale (100 being the most intense fear) their SUDS for floors 1, 2, 3, 4, 9, 19 of the virtual glass elevator and balconies. This test has been used successfully as a measure of treatment gains in previous studies of acrophobia research (Ressler et al., 2004). For the outcome analyses, we included the level of fear reported at the highest floor of the virtual elevator environment (19th floor). Higher scores indicate a worse outcome. 2 months No
See also
  Status Clinical Trial Phase
Completed NCT01963806 - ACT-smart: Smartphone-supplemented iCBT for Social Phobia and/or Panic Disorder N/A
Completed NCT00121069 - Study of Escitalopram in the Treatment of Specific Phobia Phase 2/Phase 3
Recruiting NCT03653923 - Neurophysiological Correlates of Exposition Therapy in Spider Phobia N/A
Completed NCT00184106 - RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo Phase 4
Completed NCT00051220 - Treatment for Specific Phobias in Children Phase 1/Phase 2
Completed NCT02310152 - Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE) N/A
Completed NCT02387047 - Validity of a Self-administered Questionnaire to Screen Phobia of Falling in the Elderly N/A
Completed NCT00000370 - Treatment of Social Phobia N/A
Completed NCT03012035 - The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants N/A
Completed NCT02007694 - Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants Phase 2/Phase 3
Active, not recruiting NCT03188575 - Effectiveness & Cost-effectiveness of Internet-delivered Interventions for Depression and Anxiety Disorders in IAPT N/A
Completed NCT02432703 - A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder Phase 2
Terminated NCT01574014 - Glucocorticoid Treatment for Social Phobia Phase 2
Completed NCT00734422 - Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants Phase 2/Phase 3
Not yet recruiting NCT02336802 - Threat-Avoidance Learning in Anxiety Patients N/A
Completed NCT01361074 - In Vivo Versus Augmented Reality Exposure for Small Animal Phobia N/A
Completed NCT00104195 - A Research Study of How Teens With and Without an Anxiety Disorder Make Decisions Phase 1
Completed NCT00035412 - St. John's Wort Versus Placebo in Social Phobia Phase 2
Completed NCT00128401 - Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia Phase 2
Recruiting NCT02020824 - Virtual Reality and Concept of Control in the Treatment of Acrophobia N/A