Generalised anxiety disorder MedDRA version: 14.1 Level: LLT Classification code 10018105 Term: Generalized anxiety disorder System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Lyrica
Product Name: Pregabalin
Pharmaceutical Form: Capsule, hard
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Male or female patients aged between 18-70 years • DSM-IV diagnosis of generalized anxiety disorder (GAD) • Historical evidence of treatment of current symptoms with an SSRI or SNRI for at least 6 weeks • At least ‘moderately ill’ on the Clinical Global Impression of Severity (score of 4 or more) • Anxiety symptoms of at least moderate severity (i.e. 24 or more on the Hamilton Anxiety Scale) • Depressive symptoms of not more than mild severity (i.e. less than 20 on the MADRS) 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria • Male or female patients aged less than 18 or more than 70 years • Primary diagnosis other than GAD • No historical evidence of treatment of current symptoms with an SSRI or SNRI for at least 6 weeks • Less than moderately ill on the Clinical Global Impression of Severity (CGI-S score of 3 or less) • Anxiety symptoms of less than moderate severity (i.e. 23 or less on the Hamilton Anxiety Scale) • Depressive symptoms of more than mild severity (i.e. 20 or more on the MADRS) • A primary diagnosis of an alcohol or substance use disorder • DSM-IV diagnosis of antisocial personality disorder, according to completion of the MINI • Pregnant/breastfeeding women. Patients with a primary substance abuse or dependence disorder will be excluded from participating in the study, but those with secondary substance abuse (not dependence) could be included, providing that it had temporally arisen during the ‘index episode’ of GAD, that the symptoms were regarded as being secondary to the GAD, and that the nature of the substance use was such that treatment with an SSRI or SNRI was not inadvisable. Patients with coexisting depressive symptoms could be included, if the patient and the doctor considered GAD was the primary diagnosis based on symptom severity and distress. However if the patient scored 20 or more on the Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery & Asberg, 1979) they would be excluded from participation in the study. The MINI includes a module to identify antisocial personality disorder, and patients who meet the criteria for this condition will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Though the pharmacological actions of pregabalin are fairly well characterised in animal models, there is little understanding of how it might modulate the emotionrelated functions of neural systems thought to underlie GAD, such as amygdala hyperactivity and prefrontal hypoactivity. The purpose of this study is to clarify the effects of pregabalin on two measures the startle response and an antisaccade task as increased knowledge of the effects of pregabalin on these neural systems in a clinical sample would permit a greater understanding of its possible mechanism of action, and this in turn could lead to refined treatment approaches.;Secondary Objective: The study is not designed to have sufficient power to ascertain the efficacy of pregabalin in augmentation treatment, partly because this has already been established in a large randomised placebo controlled trial. However the use of detailed questionnaires and questions regarding tolerability will allow an evaluation of the effectiveness and acceptability (or otherwise) of pregabalin, in patients who are more representative of those seen within wider clinical practice.;Primary end point(s): baseline, Week 2, Week 4 and Week 6;Timepoint(s) of evaluation of this end point: baseline, Week 2, Week 4 and Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): baseline, Week 2, Week 4 and Week 6;Timepoint(s) of evaluation of this end point: baseline, Week 2, Week 4 and Week 6 | — |
Countries
United Kingdom
Contacts
Public ContactMagda Nowak
University of Southampton
Outcome results
None listed