NCT00026637

Brief Summary

To define the benefits of antidepressant treatment or cognitive behavior therapy on mood, function, and quality of life in persons with depression and refractory epilepsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3 depression

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_3 depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2001

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

5.8 years

First QC Date

November 14, 2001

Last Update Submit

November 2, 2017

Conditions

DepressionEpilepsy

Keywords

depressionepilepsyseizures

Outcome Measures

Primary Outcomes (1)

  • MINI

    completed at screen and 16 weeks

Secondary Outcomes (5)

  • Depression as measured by the CES-D

    completed every 2 weeks during the 16 week intervention period and at 6 month and 1 year follow ups

  • Health Related Quality of life as measured by the QOILIE-89

    completed every 4 weeks during the 16 week intervention period and at 6 month and 1 year follow ups

  • antiepileptic medication compliance

    assessed at 16 weeks

  • antiepileptic medication toxicity as measured by the AEP

    assessed every 2 weeks during the 16 week intervention period

  • seizure frequency and seizure severity

    assessed every 2 weeks during the 16 week intervention period

Study Arms (2)

Sertraline

ACTIVE COMPARATOR
Drug: sertraline

CBT

ACTIVE COMPARATOR
Behavioral: cognitive behavior therapy

Interventions

sertralineDRUG

Sertraline: 25-200mg PO (orally); Subjects begin at 25mg for week 1 and increase to 50mg at the beginning of week 2. Sertraline is increased in 50mg increments when subjects score in the depressed range on the CES-D, a questionnaire that is administered every 2 weeks over the 16 week intervention period. Subjects may reduce dosage if toxicity occurs.

Sertraline
cognitive behavior therapyBEHAVIORAL

CBT (Cognitive Behavior Therapy) - CBT is a psychotherapy based on modifying cognitions, assumptions, beliefs and behaviors, with the aim of influencing disturbed emotions. Subjects will meet with a trained CBT therapist for 1 hour each week over the 16 week intervention period and will be given assignments to work on each week.

Also known as: CBT
CBT

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have a seizure disorder.
  • Must meet the DSM-IV criteria for major depression.
  • Must be willing to provide written informed consent.
  • Must be age 21 to 75 years old.
  • Must be compliant, cooperative, reliable, and able to follow instructions, and to visit the clinic on schedule.

You may not qualify if:

  • Have active suicidal or homicidal ideation.
  • Have current alcohol or other substance abuse disorders or a history of bipolar depression or any psychotic disorder.
  • Are pregnant or lactating.
  • Are known to be hypersensitive to sertraline.
  • Have a progressive central nervous system disorder (such as a tumor or multiple sclerosis), or severe hepatic or renal disease (serum creatinine \>3 mg/dl).
  • Currently taking an antidepressant medication or seeing a therapist regularly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Maguire MJ, Marson AG, Nevitt SJ. Antidepressants for people with epilepsy and depression. Cochrane Database Syst Rev. 2021 Apr 16;4(4):CD010682. doi: 10.1002/14651858.CD010682.pub3.

    PMID: 33860531DERIVED

MeSH Terms

Conditions

DepressionEpilepsySeizures

Interventions

SertralineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Frank Gilliam, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2001

First Posted

November 15, 2001

Study Start

August 1, 2001

Primary Completion

June 1, 2007

Study Completion

June 1, 2008

Last Updated

November 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)