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

Overview

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).

Full Title of Study: “Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2012

Interventions

  • Drug: Pregabalin
    • Pregabalin 150-300 mg given twice a day
  • Drug: Lorazepam
    • Lorazepam 3-4 mg given twice a day
  • Drug: Pregabalin
    • Pregabalin 450-600 mg given twice a day
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Experimental: 1
  • Active Comparator: 2
  • Experimental: 3
  • Placebo Comparator: 4

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)
    • Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)
    • Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.
  • Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)
    • Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
    • Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.
  • Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)
    • Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
    • Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.
  • Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)
    • Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)
    • DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.
  • Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)
    • Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
    • DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.
  • Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)
    • Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
    • DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.
  • 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
    • Time Frame: Baseline, Week 1, 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 Baseline in Physician’s Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2
    • Time Frame: Baseline, Week 1, 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 Baseline in Physician’s Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2
    • Time Frame: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] 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.
  • Physician’s Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)
    • Time Frame: Week 1, 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.
  • Physician’s Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)
    • Time Frame: Week 1, 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.
  • Physician’s Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)
    • Time Frame: Week 1, 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.
  • 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
    • Time Frame: Last visit on treatment, Week 1, 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 Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2
    • Time Frame: Last visit on treatment, Week 1, 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); possible range 0 to 56. Lower score indicates less affected.
  • 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
    • Time Frame: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] 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.
  • Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)
    • Time Frame: Week 1, 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.
  • Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)
    • Time Frame: Week 1, 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); possible range 0 to 56. Lower score indicates less affected.
  • Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)
    • Time Frame: Week 1, 2 post-treatment discontinuation (discontinuation [DC] 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.
  • Hamilton Anxiety Scale (HAM-A) Score for Period 1
    • Time Frame: Baseline, Week 12
    • 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.
  • Hamilton Anxiety Scale (HAM-A) Score for Period 2
    • Time Frame: Baseline, 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) Score at Week 12
    • Time Frame: Baseline, Week 12
    • 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) Score at Week 24
    • Time Frame: Baseline, 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.
  • Clinical Global Impression – Severity (CGI-S) Score for Period 1
    • Time Frame: Baseline, Week 12
    • CGI-S: 7-point clinician rated scale to assess severity of participant’s current illness state; range: 1 (normal – not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
  • Clinical Global Impression – Severity (CGI-S) Score for Period 2
    • Time Frame: Baseline, Week 24
    • CGI-S: 7-point clinician rated scale to assess severity of participant’s current illness state; range: 1 (normal – not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected
  • Change From Baseline in Clinical Global Impression – Severity (CGI-S) Score at Week 12
    • Time Frame: Baseline, Week 12
    • CGI-S: 7-point clinician rated scale to assess severity of participant’s current illness state; range: 1 (normal – not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
  • Change From Baseline in Clinical Global Impression – Severity (CGI-S) Score at Week 24
    • Time Frame: Baseline, Week 24
    • CGI-S: 7-point clinician rated scale to assess severity of participant’s current illness state; range: 1 (normal – not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected
  • Clinical Global Impression – Improvement (CGI-I) Score at the End of Period 1
    • Time Frame: Week 12
    • CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
  • Clinical Global Impression – Improvement (CGI-I) Score at the End of Period 2
    • Time Frame: Week 24
    • CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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