Major DepressionPhase 4NCT00595699
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy
A Phase 4 study testing escitalopram in people with Major Depression and Temporal Lobe Epilepsy, run by Conrad, Erich J., M.D. at 1 site in United States.
Trial summary
This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of major depression in subjects with temporal lobe epilepsy. The purpose of the study is to measure the severity and change in depressive and anxiety symptoms after 10 weeks of study treatment with escitalopram or placebo as… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression, Temporal Lobe Epilepsy
- What is being tested?
- escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2009
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a confirmed diagnosis of temporal lobe epilepsy
- Subject meets DSM-IV criteria for Major Depression
- MADRS greater than or equal to 15 at screening and baseline
- Subject between ages of 18 and 65
- Female subjects of childbearing potential must take adequate contraceptive precautions (methods with a published failure rate of less than 1% per year, or condom/diaphragm, or diaphragm/spermicide)
- Subject must provide voluntary signed informed consent approved by the Institutional Review Board of LSU Health Sciences Center
Who cannot join
- Any other primary axis I diagnosis other than Major Depression
- The presence of psychogenic, non-epileptic seizures
- A history of non-response to two or more antidepressants given for an adequate therapeutic trial
- The presence of substance abuse or dependence in past six months
- The presence of clinically significant malnutrition, cardiac, hepatic or renal disease that might endanger the safety of the subject
- Pregnancy or nursing
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- Any subjects with suspected mental retardation, psychotic disorder or dementia
- Subjects whose anticonvulsant medication regimen includes phenobarbital
- Individuals who will require psychotropic medications such as benzodiazepines or medications likely to cause significant effects on mood or anxiety as outlined in section 5.4
- Cognitive-behavioral therapy will not be allowed during the course of the study. Other psychotherapeutic modalities (supportive, psychoanalytic, etc.) will be allowed only if the individual has been in therapy for the previous 12 weeks and plans to remain in therapy throughout the duration of the study.
- Individuals who in the opinion of the investigator would not be able to understand or comply with study requirements
- Individuals with a known hypersensitivity to escitalopram or any of its ingredients
- Individuals who in the opinion of the investigator present a significant risk of suicide, or have had a significant suicide attempt in the past two years.
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Anxiety and Mood Disorders Clinic
New Orleans, Louisiana, 70115
About this study
Official title: Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-blind, Placebo-controlled Study.
This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of major depression in subjects with temporal lobe epilepsy. The purpose of the study is to measure the severity and change in depressive and anxiety symptoms after 10 weeks of study treatment with escitalopram or placebo as measured by certain rating scales and questionnaires. In addition, the study will measure the frequency of seizures using a patient diary during the study. Finally, the study will assess the change in the quality of life using rating scales.
- Conditions
- Major Depression, Temporal Lobe Epilepsy
- Being tested
- escitalopram, placebo
- Medical subject headings
- Depressive Disorder, Major, Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Also called Lexapro
10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study
placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Double-blind Receives: Drug: placebo |
| 1 | Experimental | escitalopram group Receives: Drug: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery And Asberg Depression Rating Scale
Measured: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
Secondary outcomes (1)
Clinician's Global Impression Severity and Improvement subscales
Measured: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startNov 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conrad, Erich J., M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Erich J Conrad, M.D, Principal investigator, LSUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595699
- Sponsor's protocol ID
- LXP-MD-116
- Other IDs
- LSUHSC IRB #6653
- Status last verified
- Jan 2008
- First submitted
- 3 Jan 2008
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT00595699
- Acronym / sponsor ID
- LXP-MD-116
- Conditions
- Major Depression, Temporal Lobe Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Conrad, Erich J., M.D.University, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Nov 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Jan 2008 (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.
This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of major depression in subjects with temporal lobe epilepsy. The purpose of the study is to measure the severity and change in depressive and anxiety symptoms after 10 weeks of study treatment with escitalopram or placebo as measured by certain rating scales and questionnaires. In addition, the study will measure the frequency of seizures using a patient diary during the study. Finally, the study will assess the change in the quality of life using rating scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: placeboDouble-blind |
| 1 | Experimental | Drug: escitalopramescitalopram group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has a confirmed diagnosis of temporal lobe epilepsy
- Subject meets DSM-IV criteria for Major Depression
- MADRS greater than or equal to 15 at screening and baseline
- Subject between ages of 18 and 65
- Female subjects of childbearing potential must take adequate contraceptive precautions (methods with a published failure rate of less than 1% per year, or condom/diaphragm, or diaphragm/spermicide)
Key exclusion criteria (13 listed)
- Any other primary axis I diagnosis other than Major Depression
- The presence of psychogenic, non-epileptic seizures
- A history of non-response to two or more antidepressants given for an adequate therapeutic trial
- The presence of substance abuse or dependence in past six months
- The presence of clinically significant malnutrition, cardiac, hepatic or renal disease that might endanger the safety of the subject
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 |
|---|---|---|
| escitalopramAlso: Lexapro10 mg daily for the first week followed by an increase to 20 mg daily for the remainder of the study | Drug | 1 |
| placeboPlacebo | Drug | 2 |
Primary outcome
Montgomery And Asberg Depression Rating Scale
Time frame: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
1 secondary outcome
Clinician's Global Impression Severity and Improvement subscales
Time frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
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 18 Jul 2011.
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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.
Erich J Conrad, M.D principal investigator
LSUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing escitalopram in people with Major Depression and Temporal Lobe Epilepsy, run by Conrad, Erich J., M.D. at 1 site 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 6 inclusion and 13 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 18 Jul 2011. 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 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Montgomery And Asberg Depression Rating Scale (time frame: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2011.