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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34949
Enrollment
72
Registered
2010-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panic disorder with agorphobia /panic attack with fobia open spaces

Interventions

Exposure therapy, by protocol, and depending on the condition a possible medical intervention by D-cycloserine.

Sponsors

Universiteit Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults patients (between 18 and 55 years) with panic disorder + agoraphobia (PD+AGO), according to DSM-IV diagnoses as established using standardized interviews. And are referred to the outpatient clinic of one of the participating centres.

Exclusion criteria

Exclusion criteria: Patients with : - co-morbided psychiatric disorders (severe major depressive disorder, bipolar disorder, psychosis, dependence and abuse of alcohol, drugs in 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, and a history of allergies, adverse reactions or rash on medication. - Currently taking benzodiazepines, since benzodiazepine might hamper therapy effect. - Pregnancy or breastfeeding at the time of the study - use of isoniazide and cycloserines. - use of variable dosages of antidepressiva (SSRI*s of TCA)( the use of a fixed dosage of antidepressiva is NOT an exclusion criterium) - An evidence based behavioural therapy for panic disorder during the past 12 month.

Design outcomes

Primary

MeasureTime frame
The primary outcome measures will be: - the Panic Disorder Severity Scale (PDSS; Shear et al. 1997; taken weekly before each session) - the Subjective Unit of Distress Scale (SUDS; Wolpe 1969), taken weekly before and after each session.

Secondary

MeasureTime frame
Secondary outcome measures: The following measures will be taken at baseline, after the 4th and 7th sessions, post-test and FU: - Beck Anxiety Inventory (BAI; Beck, 1990) - the Agoraphobic Cognitions Questionnaire (ACQ, Chambless, 1985). - the Mobility Inventory (MI; Chambless, 1985; measures amount of agoraphobic avoidance; taken after every three sessions). - Beck depression inventory II (BDI-II, Beck, 1987) of Hamilton (Alleen bij baseline of doen we alleen BDI?) - Outcome Questionnaire (OQ-45; Lambert, Huefner, & Reisinger, 1996) - Sheehan Disability Scales (SDS; Sheehan, 1998). - WHOQOL (Quality of Life; WHOQOL Group, 1996) - The Body Symptoms Questionnaire (BSQ; Chambless,1985) - Positive and Negative Affect Shedule (Watson, Clark & Tellegen, 1988) - The Fawcett side effects checklist (Fawcett, 1987). Neuropsychological tests: To investigate how DCS affects memory, learning and executive tasks, the following neuropsychological tests are administered at baseline, post-treatment and FU Intelligence: Nederlandse Leestest voor Volwassenen (NLV; Schmand, Lindeboom & van Harskamp, 1992). This is a 5-minute lasting reading task in which persons have to read aloud words with varying difficulty and frequency of mistakes and speed are monitored as outcome variables. This task is well validated in the Netherlands. Contextual learning. This task will be administered at baseline, at the UU. A virtual environment is setted at the UU (Baas et al, 2008). The participants will get a shock(US, individually only in a specific context, combined with a specific stimulus (shock). Time to learn this context will be measured. Another part of this test is the auditory startle-fase, in which the height of the physical reaction on a stimulus is measured. We used a validated procedure by J. Baas, earlier approved by the METC (procotol 05-166).The investigators have used shocks in various experiments in over 600 subjects in the last 4 years at NIMH, and in

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)