The effects of pregabalin on aspects of cognition in patients with generalized anxiety disorder

• Conditions: Generalised anxiety disorder; MedDRA version: 14.1Level: LLTClassification code 10018105Term: Generalized anxiety disorderSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-001779-35-GB
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-29
• Last Update Posted: 25 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified