DepressionCBTvsSSRINCT02262156

CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy Patients

A study testing Cognitive behavioral therapy and SSRI in people with Depression and Epilepsy, Temporal Lobe, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to compare the effect of group-cognitive-behavioral therapy (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Depression, Epilepsy, Temporal Lobe
What is being tested?: Cognitive behavioral therapy and SSRI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteMexico
Study dates: Aug 2014to Nov 2014
Phase: Interventional
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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

With Major depressive disorder according to criteria from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
Diagnosed with TLE according to the criteria of the International League Against Epilepsy
Literates had sign an informed consent
Patients on antidepressant treatments will be allowed to participate only if they had been at stable doses for more than 8 weeks and still show signs of significant depression

Who cannot join

Patients with high risk of suicide who required hospitalization
Patients who abused or are dependent on drugs
Those with a history of head trauma six months prior to the interview
Patients who have any condition that would prevent them from understanding the study or the psychotherapeutic process, such as mental retardation, psychosis, delirium, dementia, etc
Patients who have previously received CBT
Patients who have started, an antidepressant drug the last 8 weeks

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto Nacional de Neurología y Neurocirugía MVS
México, D.f., 14269

Other trials in Mexico

About this study

Official title: Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors

Read the detailed description

patients with temporal lobe epilepsy and depression will be enrolled into one of two treatment modality. The first group will receive 12 group cognitive behavioral sessions. CBT is a psychotherapy focused on the recognition and change of distorted thoughts and maladaptive behaviors.

The second group will receive treatment with the selective serotonin reuptake inhibitor sertraline or citalopram for 12 weeks. This antidepressant is wide used to treat depression in patients with TLE.

Conditions: Depression, Epilepsy, Temporal Lobe
Being tested: Cognitive behavioral therapy, SSRI
Keywords: Cognitive Behavioral Therapy, Selective serotonin reuptake inhibitor, depression, epilepsy
Medical subject headings: Depression, Epilepsy, Temporal Lobe, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive behavioral therapyOther
Also called CBT
The CBT group will receive 12 weekly 90-minute sessions. Each session will be given in group form by one certified CBT therapist and one neuropsychiatrist in training on group therapy.
The CBT structure include psychoeducation, addressing dysfunctional thoughts and maladaptive behaviors; problem solving techniques, assertiveness, coping strategies and depression relapse prevention
SSRIDrug
Also called selective serotonin reuptake inhibitor, antidepressant
Patients will receive the "treatment as usual" with a SSRI: sertraline or citalopram. In patients already taking antidepressants for more than 8 weeks before enrollment but still experiencing depressive symptoms, treatment could be optimized either by augmenting the dose of his antidepressant or by changing to one of the SSRI mentioned.

Study groups in NCT02262156
Study group	Role	What they receive
Cognitive behavioral Therapy	Experimental	CBT program to be used in group modality that focused on managing symptoms of depression in patients with epilepsy. 12 CBT sessions, consisting of one weekly 90-minute session for 12 consecutive weeks. Receives: Other: Cognitive behavioral therapy
Selective serotonin euptake inhibitor	Active comparator	Patients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria. Receives: Drug: SSRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Beck Depression Inventory score
Measured: baseline, 6 weeks and 12 weeks

Secondary outcomes (2)

Quality of Life in Epilepsy Scale
the quality of life in epilepsy scale measures the patients perceived quality of life. Higher score indicates better quality of life. score goes from 0 to 100
Measured: baseline, 6 weeks and 12 weeks
Hospital anxiety and depression scale (HADS)
the HADS measures severity of symptoms of anxiety and depression. Lower scores indicates less symptoms
Measured: baseline, 4weeks and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Nov 2014

First posted10 Oct 2014 (estimated)
Study startAug 2014
Primary completionOct 2014
Study completionNov 2014

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.
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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02262156
Sponsor's protocol ID: 49/06
Other IDs: U1111-1158-3147
Acronym: CBTvsSSRI
Status last verified: Oct 2014
First submitted: 7 Oct 2014
Last updated: 30 Mar 2015
Results posted: No
Data monitoring committee: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Of Depression In Patients With Temporal Lobe Epilepsy: Comparative Study Of Cognitive Behavioral Therapy Vs. Selective Serotonin Reuptake Inhibitors
ClinicalTrials.gov ID: NCT02262156
Acronym / sponsor ID: CBTvsSSRI / 49/06
Conditions: Depression, Epilepsy, Temporal Lobe
Keywords: Cognitive Behavioral Therapy, Selective serotonin reuptake inhibitor, depression, epilepsy
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUniversity, hospital or other
Study start: Aug 2014
Primary completion: Oct 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 10 Oct 2014 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cognitive behavioral Therapy	Experimental	Other: Cognitive behavioral therapyCBT program to be used in group modality that focused on managing symptoms of depression in patients with epilepsy. 12 CBT sessions, consisting of one weekly 90-minute session for 12 consecutive weeks.
Selective serotonin euptake inhibitor	Active comparator	Drug: SSRIPatients will receive a SSRI (sertraline or citalopram) for 12 weeks. Dose will be adjusted every 4 weeks according to medical criteria.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

With Major depressive disorder according to criteria from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
Diagnosed with TLE according to the criteria of the International League Against Epilepsy
Literates had sign an informed consent
Patients on antidepressant treatments will be allowed to participate only if they had been at stable doses for more than 8 weeks and still show signs of significant depression

Key exclusion criteria (6 listed)

Patients with high risk of suicide who required hospitalization
Patients who abused or are dependent on drugs
Those with a history of head trauma six months prior to the interview
Patients who have any condition that would prevent them from understanding the study or the psychotherapeutic process, such as mental retardation, psychosis, delirium, dementia, etc
Patients who have previously received CBT

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
Cognitive behavioral therapyAlso: CBTThe CBT group will receive 12 weekly 90-minute sessions. Each session will be given in group form by one certified CBT therapist and one neuropsychiatrist in training on group therapy. The CBT structure include psychoeducation, addressing dysfunctional thoughts and maladaptive behaviors; problem solving techniques, assertiveness, coping strategies and depression relapse prevention	Other	Cognitive behavioral Therapy
SSRIAlso: selective serotonin reuptake inhibitor, antidepressantPatients will receive the "treatment as usual" with a SSRI: sertraline or citalopram. In patients already taking antidepressants for more than 8 weeks before enrollment but still experiencing depressive symptoms, treatment could be optimized either by augmenting the dose of his antidepressant or by changing to one of the SSRI mentioned.	Drug	Selective serotonin euptake inhibitor

Primary outcome

Change in Beck Depression Inventory score
Time frame: baseline, 6 weeks and 12 weeks

2 secondary outcomes

Quality of Life in Epilepsy Scale
Time frame: baseline, 6 weeks and 12 weeks
Hospital anxiety and depression scale (HADS)
Time frame: baseline, 4weeks and 12 weeks

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 30 Mar 2015.
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.

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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.

Daniel Crail-Melendez, MD principal investigator

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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.

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?

Change in Beck Depression Inventory score (time frame: baseline, 6 weeks and 12 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 NCT02262156, 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 30 Mar 2015.