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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Patients with DSM-IV criteria for PD+AGO
- Male and female, aged between 18-55years old.
- Female patients of childbearing potential must use reliable method of contraception and not be planning a pregnancy during the study period (in case of doubt a pregnancy test is provided).
- Written informed consent.
- Eligible for exposure therapy.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 doubt a pregnancy test is provided).
- 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).
- An unsuccessful evidence based behavioral therapy for panic disorder during the past 12 months (therapy resistant patients).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The first aim of the study is whether D-cycloserine (DCS) addition to exposure therapy enhances symptom reduction in panic disorder with agoraphobia. ;Secondary Objective: The second objective of the study is to establish the optimal timing of administration of DCS (directly pre- or post exposure therapy). <br>The third objective is to study the fear extinction enhancement of DCS using a neuropsychological paradigm. <br>The fourth objective is, from a health economic perspective, to establish cost-effectiveness of DCS. ;Primary end point(s): -the Panic Disorder Severity Scale (PDSS; Shear et al. 1997)<br>-the Subjective Unit of Distress Scale (SUDS; Wolpe 1969)

Secondary Outcome Measures