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Lexapro for Major Depression in Patients With Epilepsy

This study has been terminated.
(Unable to recruit targeted #)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01244724
First received: November 18, 2010
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Major Depression
Epilepsy
 Drug: Lexapro
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lexapro for Major Depression in Patients With Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Depression Epilepsy
U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Hamilton Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • National Hospital Seizure Severity Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: October 2007
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lexapro Drug: Lexapro
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.
Other Name: Escitalopram

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Subjects must be stabilized on their antiepileptic drug (AED) regimen for the previous 2 months.
  4. If a vagus nerve stimulator is in place, the settings must be unchanged for the previous 2 months.
  5. Patients must be ages 18 - 75 and have a 24 item Hamilton Depression Rating Scale Score (HAM-D) at intake >/= 20.
  6. Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.

Exclusion Criteria:

  1. 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).
  2. History of psychosis, mania or hypomania.
  3. Subjects with more than 10 seizures per month that involve impairment of consciousness, such as complex partial or generalized seizures.
  4. Subjects unable to count seizures accurately, or do not have a someone in their home who can count seizures accurately .
  5. Unstable medical or neurological disorder (other than epilepsy).
  6. Epilepsies related to a progressive neurologic disease such as a brain tumor.
  7. Substance abuse including ETOH within the past 6 months.
  8. Need for concurrent psychotropic drugs with the exception of AEDs or zolpidem for sleep.
  9. Concurrent or recent (within 3 months) entry into a new psychotherapy.
  10. Actively or acutely suicidal.
  11. Failure to respond to escitalopram or to two or more other adequate antidepressant trials in the past year.
  12. Pregnancy or lactation.

  13. Females of child bearing potential who do not practice adequate contraception.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244724

Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Forest Laboratories
Investigators
Principal Investigator: James H Kocsis, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01244724     History of Changes
Other Study ID Numbers: LXP-MD-109
Study First Received: November 18, 2010
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Epilepsy
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013