D-cycloserine (DCS) enhancement of exposure therapy in panic disorder with agoraphobia: a randomized controlled trial.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- adult patients (between 18 and 55 years old) with panic disorder with agoraphobia (PD+AGO), according to DSM IV diagnoses as established using a standardized interview.
- patients are referred to the outpatient clinic of one of the three participating centers.

Exclusion Criteria

Patients with
- comorbid psychiatric disorder (severe major depressive disorder, bipolar disorder, psychosis, dependence and/or abuse of alcohol/drugs during the past three months)
- mental deficiency
- inability to adequately read or speak Dutch
- (a history of) neurological disease (i.e. neurovascular disease, movement disorders, seizures, dementia), renal or liver abnormalities
- a history of allergies, adverse reactions or rash on medication
- currently taking benzodiazepines during the day since benzodiazepines might hamper therapy effect (use of stable dosage of evening medication is allowed)
- pregnancy or breastfeeding at the time of the study (in case of possible pregnancy, a pregnancy test will be offered)
- use of isoniazide
- use of variable dosages of antidepressiva (SSRI's or TCA's). (The use of a fixed dosage is NOT an exclusion criterium, but will be registered)
- a unsuccessful evidence based behavioral therapy for panic disorder during the past 12 months (therapy resistant patients)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- PDSS scores (the Panic Disorder Severity Scale, Shear et al. 1997), measure<br /><br>will be taken before sessions 4 and 8, after session 12 and after 3 and 6<br /><br>months follow up.<br /><br>- SUDS scores (the Subjective Unit of Distress Scale, Wolpe 1969), measured<br /><br>weekly during the session.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>De secondary outcome measurements will be taken before sessions 4 and 8, after<br /><br>session 12 and after 3 and 6 months follow up:<br /><br><br /><br>- Fawcett side effects checklist (Fawcett, 1987).<br /><br>- Positive and Negative Affect Shedule (PANAS).<br /><br>- Mobility Inventory (MI; Chambless, 1985).<br /><br>- Agoraphobis Cognitions Questionnaire (ACQ; Chambless, 1985)<br /><br>- Beck anxiety Inventory (BAI; Becl. 1990)<br /><br>- EQOL (Quality of Life; WHOQOL Group, 1996).<br /><br>- Beck depression inventory II (BDI-II, 1987).<br /><br>- Outcome questionnaire (OQ).<br /><br>- Body symptoms Questionnaire (BSQ,Chambless, 1985).<br /><br>- Sheenhan Disability Scales (SDS; Sheehan, 1998).<br /><br>- TiC-P (Hakkaart-van Rooijen, 2002)<br /><br><br /><br>- The degree of extinction during the extinction task.</p><br>