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SSRI Antidepressant
Escitalopram Combination for Depression
Phase 3
Waitlist Available
Led By Jon F. Heiser, MD
Research Sponsored by Pharmacology Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether combining escitalopram with another treatment is more effective, safe, and tolerable than escitalopram or the other treatment alone, or placebo, in people with major depressive disorder.
Who is the study for?
This trial is for adults with Major Depressive Disorder as defined by DSM-IV, experiencing a depressive episode lasting at least 12 weeks. It excludes those with seizure risks, pregnant or breastfeeding women not using birth control, and individuals with bipolar disorder, schizophrenia, OCD, mental retardation or developmental disorders.Check my eligibility
What is being tested?
The study tests the effectiveness of combining escitalopram with other treatments versus using it alone or a placebo in patients suffering from major depression. The goal is to see which approach works best for reducing symptoms safely and tolerably.See study design
What are the potential side effects?
Potential side effects may include nausea, sleep disturbances (like insomnia), fatigue, dry mouth, increased sweating, sexual dysfunction and weight changes. These are common side effects associated with antidepressants like escitalopram.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mental Depression
Secondary outcome measures
Hamilton Depression Rating Scale (HAMD)
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Who is running the clinical trial?
Pharmacology Research InstituteLead Sponsor
4 Previous Clinical Trials
145 Total Patients Enrolled
1 Trials studying Depression
Jon F. Heiser, MDPrincipal InvestigatorPharmacology Research Institute
Nader Oskooilar, MDPrincipal InvestigatorPharmacology Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures, stroke, significant head injury, or conditions that increase my risk of seizures.My current depressive episode has lasted for at least 12 weeks.I am not pregnant, breastfeeding, and if able to bear children, I am using reliable birth control.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research being conducted with subjects who are over 25 years old?
"The trial's requirements state that all participants must be between 18-80 years old."
Answered by AI
Are there risks associated with this treatment method?
"There is some prior clinical data supporting the safety of this intervention, as it is a Phase 3 trial, thus it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Pharmacology Research Institute
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
What specifically do you require from me ?
PatientReceived 1 prior treatment
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