DepressionPhase 3NCT00026637
Depression and Health Outcomes in Refractory Epilepsy
A Phase 3 study testing sertraline and cognitive behavior therapy in people with Depression and Epilepsy, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Depression, Epilepsy
- What is being tested?
- sertraline and cognitive behavior therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2001to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Medical Center
New York, New York, 10032
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the detailed description
This randomized clinical trial will be conducted to compare the drug sertraline to cognitive behavioral therapy on symptoms of depression, antiepileptic medication compliance, seizure frequency, and quality of life outcomes in persons with depression and a seizure disorder or epilepsy. Approximately 140 persons will be enrolled in this study over a period of five years. Individual participation will last approximately 16 weeks. Study participants will be chosen randomly to receive either the study medication (sertraline) or cognitive behavior therapy for 16 weeks. Sertraline is approved by the Food and Drug Administration (FDA). Subjects who receive cognitive behavior therapy will be provided with a one-hour individual session with a licensed clinical psychologist each week for 15 weeks. All study participants will attend scheduled clinic visits every 4 weeks for 16 weeks.
- Conditions
- Depression, Epilepsy
- Being tested
- sertraline, cognitive behavior therapy
- Keywords
- depression, epilepsy, seizures
- Medical subject headings
- Depression, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
cognitive behavior therapyBehavioural
Also called CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Active comparator | Not described Receives: Drug: sertraline |
| CBT | Active comparator | Not described Receives: Behavioral: cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MINI
Measured: completed at screen and 16 weeks
Secondary outcomes (5)
Depression as measured by the CES-D
Measured: 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
Measured: completed every 4 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
antiepileptic medication compliance
Measured: assessed at 16 weeks
antiepileptic medication toxicity as measured by the AEP
Measured: assessed every 2 weeks during the 16 week intervention period
seizure frequency and seizure severity
Measured: assessed every 2 weeks during the 16 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study startAug 2001
- Primary completionJun 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Gilliam, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026637
- Sponsor's protocol ID
- AAAB1084
- Other IDs
- 5R01NS040808-04
- Status last verified
- Nov 2017
- First submitted
- 14 Nov 2001
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33860531
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Health Outcomes in Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT00026637
- Acronym / sponsor ID
- AAAB1084
- Conditions
- Depression, Epilepsy
- Keywords
- depression, epilepsy, seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Aug 2001
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized clinical trial will be conducted to compare the drug sertraline to cognitive behavioral therapy on symptoms of depression, antiepileptic medication compliance, seizure frequency, and quality of life outcomes in persons with depression and a seizure disorder or epilepsy. Approximately 140 persons will be enrolled in this study over a period of five years. Individual participation will last approximately 16 weeks. Study participants will be chosen randomly to receive either the study medication (sertraline) or cognitive behavior therapy for 16 weeks. Sertraline is approved by the Food and Drug Administration (FDA). Subjects who receive cognitive behavior therapy will be provided with a one-hour individual session with a licensed clinical psychologist each week for 15 weeks. All study participants will attend scheduled clinic visits every 4 weeks for 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Active comparator | Drug: sertraline |
| CBT | Active comparator | Behavioral: cognitive behavior therapy |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertralineSertraline: 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. | Drug | Sertraline |
| cognitive behavior therapyAlso: CBTCBT (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. | Behavioural | CBT |
Primary outcome
MINI
Time frame: completed at screen and 16 weeks
5 secondary outcomes
Depression as measured by the CES-D
Time frame: 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
Time frame: completed every 4 weeks during the 16 week intervention period and at 6 month and 1 year follow ups
antiepileptic medication compliance
Time frame: assessed at 16 weeks
antiepileptic medication toxicity as measured by the AEP
Time frame: assessed every 2 weeks during the 16 week intervention period
seizure frequency and seizure severity
Time frame: assessed every 2 weeks during the 16 week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 33860531Maguire 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Gilliam, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sertraline and cognitive behavior therapy in people with Depression and Epilepsy, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MINI (time frame: completed at screen and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00026637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.