Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder
Overview
- Phase
- Phase 4
- Intervention
- Pregabalin
- Conditions
- Generalized Anxiety Disorder
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 615
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis Generalized Anxiety Disorder
- •HAM-A score \>=18 and HAM-D (item 1) score \>=2 at screening and baseline
- •Needs pharmacological treatment
Exclusion Criteria
- •Current or past diagnosis of any other DSM IV Axis I disorders
- •A history of failed treatment with a benzodiazepine
- •Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
Arms & Interventions
1
Intervention: Pregabalin
2
Intervention: Lorazepam
3
Intervention: Pregabalin
4
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
Time Frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2
Time Frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
Time Frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
Time Frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
Time Frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
Time Frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
Time Frame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2
Time Frame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
Time Frame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
Time Frame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
Time Frame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
Time Frame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Secondary Outcomes
- Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2(Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24))
- Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24))
- Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2(Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2(Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2(Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24))
- Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24))
- Hamilton Anxiety Scale (HAM-A) Score for Period 1(Baseline, Week 12)
- Hamilton Anxiety Scale (HAM-A) Score for Period 2(Baseline, Week 24)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12(Baseline, Week 12)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24(Baseline, Week 24)
- Clinical Global Impression - Severity (CGI-S) Score for Period 1(Baseline, Week 12)
- Clinical Global Impression - Severity (CGI-S) Score for Period 2(Baseline, Week 24)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12(Baseline, Week 12)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24(Baseline, Week 24)
- Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1(Week 12)
- Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2(Week 24)
- Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2(Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24))
- Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24))
- Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2(Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9))