Generalized Anxiety Disorder (GAD) MedDRA version: 9.1 Level: LLT Classification code 10018105 Term: Generalized anxiety disorder
Conditions
Interventions
Trade Name: Lyrica®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
P
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United states
Pfizer Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Males and females 18 years of age or older. 2. Primary DSM IV diagnosis of GAD (DSM IV, 300.02), as confirmed by the MINI structured interview. 3. All patients must have a total HAM A score =22 at screening. 4. Patients who initiated GAD treatment prior to entering the study must have a CGI I = 3 minimally improved or worse as determined by the physician’s assessment of a patient’s response to the treatment (escitalopram, paroxetine, or venlafaxine XR) at study enrollment (Visit 1). 5. Patients who initiated the GAD treatment at enrollment (Visit 1) must have a minimum score of CGI S = 4 at Screening (Visit 0) and Enrollment (Visit 1). 6. Historical failure to respond optimally to a GAD treatment (CGI I =3 minimally improved or worse). This treatment must be a different treatment than the one used during the open label optimization phase of this study and must be included in the treatments listed in Table 1, Appendix 1 (in the protocol). GAD treatments not included in Table 1, Appendix 1 (in the protocol), but which the investigator considers to meet this criterion must be discussed with and approved by the sponsor in advance of enrolling the patient in the study. 7. Able to understand and cooperate with study procedures and to give informed consent. 8. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. 9. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: 1. Current* primary DSM IV diagnosis of major depressive disorder (MDD single episode, recurrent) with or without seasonal pattern, dysthymic disorder, depressive disorder NOS, social phobia, panic disorder with or without agoraphobia, post traumatic stress disorder (PTSD), dissociative disorder, borderline personality disorder, obsessive compulsive disorder, antisocial personality disorder, as defined in the DSM IV TR. If a subject has a past misdiagnosis of any of these disorders, the investigator will need to contact the sponsor prior to screening. 2. Past and/or current DSM IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder). 3. DSM IV substance (except for nicotine and caffeine) dependence within the past 30 days. 4. Presence of comorbid personality disorders (Axis II) based on DSM IV criteria per the investigator’s clinical judgment. 5. Suicide risk by history, self report, or clinically judged to be at serious suicidal or homicidal risk. 6. No change is permitted in the status of psychotherapy for the duration of the study. Ongoing psychotherapy of stable intensity is allowed. 7. Urine drug screen at screening (Visit 0) positive for amphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine. At randomization drug screen positive subjects for any of these substances or THC are excluded from participation in the double blind phase. 8. Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder, including, but not limited to: • Any seizure disorder; • Uncorrected hypothyroidism or hyperthyroidism. Patients must be on stable thyroid replacement therapy for hypothyroidism for at least 2 weeks prior to screening (Visit 0); • History of life threatening neoplasm treated within the last 5 years, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin. 9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal. 10. Platelet count 150 or 60 mL/min, the subject is not excluded. For SI units see Section 7.5. 13. Clinically significant abnormal electrocardiogram (ECG), including but not limited to the following abnormalities: • Rhythm Conduction: Premature ventricular contractions >10/min; ventricular tachycardia; ventricular flutter; ventricular fibrillation; second degree AV block (Mobitz Type 1); second degree AV block (Mobitz Type 2); complete heart block; Wolff Parkinson White Syndrome; or left bundle branch block complete; • Myocardial infarction: Recent or acute (500 msec); or QRS prolongation (>140
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo as an adjunctive treatment in patients with GAD who partially responded to a standard GAD treatment. Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM A) scores from baseline (Visit 8, Week 0) observed following 8 weeks of double blind treatment (Visit 15, Week 8 or at earlier termination during the double blind treatment phase) and analyzed using a mixed linear model for repeated measures.;Secondary Objective: ;Primary end point(s): The change in the HAM A total score from Baseline (start of double blind phase, Visit 8, Week 0) to termination of the double blind phase (Visit 15, Week 8 or at earlier termination if withdrawn from the study during the double blind phase) will be analyzed using a linear mixed model for repeated measures using the method of restricted maximum likelihood estimation. | — |
Countries
Czech Republic, Estonia, Finland, Hungary
Outcome results
None listed