Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline

NCT01309074 | Withdrawn Phase 4

• 1 other identifier: GA0082BY
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the safety \& efficacy of sertraline (up to a dose of 200mg/day) \& pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety in patients with epilepsy.

Conditions

Epilepsy; Anxiety

Keywords

Anxiety; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A.

  Change in severity of symptoms \&/o remission of symptoms of anxiety between visit 0 \& the end of treatment phase.

  27 weeks

Secondary Outcomes (1)

• Change in Quality of life measures assessed with the QOLIE-89.

  27 weeks.

Study Arms (2)

Pregabalin

EXPERIMENTAL

Pregabalin is an antiepileptic medication which has been found in double blind placebo controlled trials to be effective and safe in the treatment of primary generalized anxiety disorder. It has an indication for the treatment of this condition in Europe \& Canada but not in the US.

Drug: Pregabalin-Lyrica

Sertraline

ACTIVE COMPARATOR

Sertraline is an SSRI found to be an effective treatment of generalized anxiety disorder in controlled trials. It does not have an indication for this in this country.

Drug: Sertraline

Interventions

Pregabalin-Lyrica DRUG

Pregabalin in a dose up to 300mg/day in BID dosing.

Also known as: Lyrica.

Pregabalin

Sertraline DRUG

Sertraline in a dose up to 200mg/day in BID dosing.

Also known as: Zoloft.

Sertraline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GAD-7 total score above 10.
• Have a diagnosis of a Partial Seizure Disorder.
• Have a Hamilton-A total score 20 and above.
• years of age.
• Able to read at a fourth grade level.
• If a woman of childbearing age, agrees to use an acceptable means of birth control.

You may not qualify if:

• Unable to understand and sign a consent.
• Unable to follow instructions for the study.
• Displaying current suicidal ideation
• Having psychogenic non-epileptic seizures
• Have a history of drug or alcohol abuse.
• Use of any investigational drug within the last 30 days.
• Hypersensitivity reaction or other serious adverse event to PGB in prior trials.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Epilepsy; Anxiety Disorders

Interventions

Pregabalin; Sertraline

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; 1-Naphthylamine; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Andre M. Kanner, MD

  Director Laboratory Encephalography

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

US (1)