Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

Not Applicable

• Conditions: -F411 Generalised anxiety disorder; Generalised anxiety disorder; F411

• Registration Number: PER-099-09
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Men and women between the ages of 18 and 65, Women with the possibility of becoming pregnant should use an acceptable method of birth control during the study period (refer to Section 4.3 Lifestyle Guide).
• Main Diagnosis in accordance with the GAD DSM-IV (DSM-IV, 300.02), as established by an authorized psychiatrist or clinical psychologist and confirmed through a structured interview called MINI International Neuropsychiatric Interview.
• Total HAM-A score> 18 and point # 1 on the HAM-D with a depressive mood score <2 both during the Screening visit (Visit 1) and at the Baseline (Visit 2) with the in order to ensure the prevalence of anxiety symptoms over depression.
• Subjects that require pharmacological treatment for GAD.
• Subjects who are able to understand and cooperate with the study procedures and grant their informed consent.
• Proof of an informed consent document signed personally and dated in which it is indicated that the subject (or his legally acceptable representative) has been informed about all aspects concerning the study.
• Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria

• Present or past diagnosis of any other disorder indicated in Axis 1 of the DSM-IV (including current premenstrual dysphoric disorder)
• Current or previous abuse or dependence of the substance in the DSM-IV (except for nicotine and caffeine).
• Presence of borderline and comorbid antisocial personality disorders, according to the DSM-IV criteria and the investigator´s clinical judgment,
• Risk and suicidal history within the last two years, self-informed or clinically considered as serious suicide or homicidal risk.
• Discontinuation or initiation of psychotherapy for GAD during the study. Subjects with stable intensity psychotherapy for at least 6 weeks or more will be allowed to enter the study.
• Daily use of benzodiazepines for the treatment of GAD (> 5 days / week) during the 4 weeks prior to screening. Occasional use of benzodiazepine is allowed for insomnia (for example, 2 6 3 times per month), but not within 2 weeks of the baseline.
• Current use of psychotropic medications that cannot be interrupted two weeks before the start of the study (5 weeks for fluoxetine).
• History of a failed treatment with benzodiazepine. as determined by the clinical criteria of the investigator and taking into account the adequacy of the dose and the duration of treatment.
• Known sensitivity to lorazepam or other benzodiazepines.
• Previous exposure to pregabalin.
• Positive detection of drugs in urine during the selection visit of any of the following substances or classes of compounds: amphetamines, barbiturates, benzodiazepines, narcotics, sedatives and hypnogens, cocaine, phencyclidine, cannabinoids or other illegal or illegal drugs.
• Positive test to the breath analyzer during the selection visit.
• Any clinically significant, serious or unstable disorder of the hematological, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological type.
• Levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 3 times the normal upper limit.
• Platelet count <100,000 / mm3.
• Serum sodium> 150 or <130 mEq / L.
• Creatinine clearance (CLcr) <60 mL / min (estimated by the Cockroft-Gault method).
• Clinically significant electrocardiogram (ECO) abnormalities.
• Pregnancy or breastfeeding.
• Participation in a study with a drug under experimentation within the last 30 days.
• Other medical or psychiatric disorder, acute or chronic, severe or laboratory abnormality that could increase the risk associated with participating in the study or with the administration of the product under investigation or that could interfere with the interpretation of the study results and, at the discretion of the researcher or the sponsor, they could make the subject unsuitable for admission to this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified