Lexapro for Major Depression in Patients With Epilepsy

NCT01244724 | Terminated Phase 4 Results

• 1 other identifier: LXP-MD-109
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective will be to pilot the use of escitalopram for the treatment of major depression in patients with epilepsy. The secondary objectives will be to determine effect sizes on scales measuring depressive symptoms, physical symptoms, psychosocial function and quality of life, and to evaluate safety in the population of patients with epilepsy. These results will be used to evaluate the possibility of a future double-blind, placebo controlled RCT of escitalopram for the treatment of major depression in patients with epilepsy.

Conditions

Major Depression; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale

  Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)

  12 weeks

Secondary Outcomes (1)

• National Hospital Seizure Severity Scale

  12 Weeks

Study Arms (1)

Lexapro

EXPERIMENTAL

escitalopram 10 mg or 20 mg/d

Drug: Lexapro

Interventions

Lexapro DRUG

Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.

Also known as: Escitalopram

Lexapro

Eligibility Criteria

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

You may qualify if:

• Patients will be 20 males or females above the age of 18 with a current major depressive episode, as defined by DSM-IV and assessed on the MINI, of at least 4 weeks duration.
• All subjects must have epilepsy, defined as the recurrence of seizures that are unprovoked and unpredictable, requiring treatment with an anti-epileptic medication under the care of a neurologist.
• Subjects must be stabilized on their antiepileptic drug (AED) regimen for the previous 2 months.
• If a vagus nerve stimulator is in place, the settings must be unchanged for the previous 2 months.
• Patients must be ages 18 - 75 and have a 24 item Hamilton Depression Rating Scale Score (HAM-D) at intake \>/= 20.
• Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.

You may not qualify if:

• Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder(defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
• History of psychosis, mania or hypomania.
• Subjects with more than 10 seizures per month that involve impairment of consciousness, such as complex partial or generalized seizures.
• Subjects unable to count seizures accurately, or do not have a someone in their home who can count seizures accurately .
• Unstable medical or neurological disorder (other than epilepsy).
• Epilepsies related to a progressive neurologic disease such as a brain tumor.
• Substance abuse including ETOH within the past 6 months.
• Need for concurrent psychotropic drugs with the exception of AEDs or zolpidem for sleep.
• Concurrent or recent (within 3 months) entry into a new psychotherapy.
• Actively or acutely suicidal.
• Failure to respond to escitalopram or to two or more other adequate antidepressant trials in the past year.
• Pregnancy or lactation.
• Females of child bearing potential who do not practice adequate contraception.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Epilepsy

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: James H. Kocsis, M.D.
• Organization: Weill Cornell Medical College

jhk2002@med.cornell.edu

212-746-5913

Study Officials

• James H Kocsis, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: October 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 11, 2018
• Results First Posted: August 3, 2015

Record last verified: 2018-06

Locations

US (1)