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

NCT00624780 | Completed Phase 4 Results DMC

• 1 other identifier: A0081147
• Study Type: interventional
• Target: 615
• Locations: 16 countries
• Sites: 57

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).

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (12)

• Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1

  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.

  Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)

• Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2

  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.

  Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)

• Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1

  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.

  Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

• Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2

  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.

  Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

• Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1

  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.

  Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

• Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2

  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.

  Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

• 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

  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.

  Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)

• 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

  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.

  Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)

• Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1

  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.

  Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

• Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2

  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.

  Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)

• Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1

  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.

  Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

• Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2

  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.

  Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

Secondary Outcomes (28)

• 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)

• 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)

Other Outcomes (2)

• Sheehan-Suicidality Tracking Scale (S-STS) Score

  Baseline up to Week 24

• Number of Participants With Treatment-Emergent Adverse Events (AEs)

  Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2)

Study Arms (4)

1

EXPERIMENTAL

Drug: Pregabalin

2

ACTIVE COMPARATOR

Drug: Lorazepam

3

EXPERIMENTAL

Drug: Pregabalin

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregabalin DRUG

Pregabalin 150-300 mg given twice a day

Also known as: Lyrica

1

Lorazepam DRUG

Lorazepam 3-4 mg given twice a day

2

Placebo DRUG

Placebo

4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis Generalized Anxiety Disorder
• HAM-A score \>=18 and HAM-D (item 1) score \>=2 at screening and baseline
• Needs pharmacological treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (57)

Pfizer Investigational Site

La Plata, Buenos Aires, B1904ADM, Argentina

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Lanús, Prov. de Buenos Aires, B1824IBR, Argentina

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Buenos Aires, C1115AAJ, Argentina

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Buenos Aires, C1405BOA, Argentina

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Buenos Aires, C1428AQK, Argentina

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Vienna, A-1010, Austria

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Vienna, A-1090, Austria

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San José, 00000, Costa Rica

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San José, Costa Rica

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Rijeka, 51000, Croatia

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Split, 21000, Croatia

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Zagreb, 10000, Croatia

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Brno, 602 00, Czechia

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České Budějovice, 370 87, Czechia

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Litoměřice, 412 01, Czechia

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Lnáře, 387 42, Czechia

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Mělník, 276 01, Czechia

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Prague, 120 00, Czechia

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Prague, 160 00, Czechia

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Praha 10- Strasnice, 10000, Czechia

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Strakonice, 386 01, Czechia

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Espoo, 02650, Finland

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HUS, 00029, Finland

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Joensuu, 80100, Finland

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Kuopio, 70110, Finland

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Seinäjoki, 60100, Finland

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Turku, 20100, Finland

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Athens, 11528, Greece

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Ellisbridge, Ahmedabad, 380 006, India

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Tirupati, Andhra Pradesh, 517 507, India

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Mangalore, Karnataka, 575001, India

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Pune, Maharashtra, 411 030, India

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Chennai, Tamil Nadu, 600 003, India

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Denpasar, Bali, Indonesia

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Jakarta, Jakarta Selatan, Indonesia

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Jakarta Selatan, Jakarta Special Capital Region, 10430, Indonesia

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Surabaya, Indonesia

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Kaunas, 50185, Lithuania

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Kaunas, 50425, Lithuania

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Klaipėda, 94231, Lithuania

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Vilnius, 09112, Lithuania

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Acapulco de Juárez, Guerrero, 39670, Mexico

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Zapopan, Jalisco, 45170, Mexico

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Mexico City, 14269, Mexico

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Khotkovo, Moscow Region, 142601, Russia

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Moscow, 107076, Russia

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Moscow, 115522, Russia

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Moscow, 119021, Russia

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Moscow, 125367, Russia

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Saint Petersburg, 192019, Russia

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Belgrade, 11000, Serbia

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Kragujevac, 34000, Serbia

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Ljubljana, Slovenia

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Langreo, Principality of Asturias, 33900, Spain

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Zamora, 49021, Spain

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Istanbul, 34203, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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Related Publications (1)

• Kasper S, Iglesias-Garcia C, Schweizer E, Wilson J, DuBrava S, Prieto R, Pitman VW, Knapp L. Pregabalin long-term treatment and assessment of discontinuation in patients with generalized anxiety disorder. Int J Neuropsychopharmacol. 2014 May;17(5):685-95. doi: 10.1017/S1461145713001557. Epub 2013 Dec 19.

  PMID: 24351233 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Pregabalin; Lorazepam

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 27, 2008
• Study Start: May 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: April 19, 2013

Record last verified: 2012-09

Locations

GR (1); RU (6); ES (2); IN (5); SE (2); AU (2); ME (3); SL (1); CR (3); FI (6); LI (4); AR (5); CO (2); ID (4); TU (2); CZ (9)