DepressionPhase 4NCT00221494
Can Additional Drug Therapy Accelerate Response Time to Antidepressants
A Phase 4 study of Depression, run by Mark Frye at 1 site in United States.
Trial summary
Antidepressants are commonly prescribed and are effective for treating depression. However, they generally take 4-6 weeks for a therapeutic response. This study is evaluating whether simultaneous treatment with thyroid hormone or pindolol can decrease the response time ("getting better faster") in patients who are… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jun 2006
- 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
- Patients, male and female, between the ages of 18 to 65
- DSM-IV criteria for major depressive disorder
- No prior SSRI medication treatment (if a patient has discontinued a non-SSRI medication for side effects, they will not be excluded)
- Ability to be followed clinically for 6 weeks
- Each patient must understand the nature of the study and must sign an informed consent form
Who cannot join
- Severe suicidality (as defined by Beck Depression Inventory Question 9, responses 2 or 3)
- Major Axis I mental illness other than major depressive disorder
- Unstable medical health specifically cardiovascular disease, abnormal EKG, history of severe drug allergy, poorly controlled diabetes, and asthma (pindolol contraindication)
- History of thyroid disease or abnormal TFT's (stage I or II)
- Need for adjunctive antipsychotic use or additional benzodiazepine during the study
- Pregnancy
- Seizure disorder
- A positive urine toxicology screen
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Neuropsychiatric Institute
Los Angeles, California, 90095
About this study
Official title: Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-blind, Placebo-controlled Randomization Research Study for Major Depression
Antidepressants are commonly prescribed and are effective for treating depression. However, they generally take 4-6 weeks for a therapeutic response. This study is evaluating whether simultaneous treatment with thyroid hormone or pindolol can decrease the response time ("getting better faster") in patients who are starting SSRI treatment.
Read the detailed description
Major depression is an illness with substantial personal and economic morbidity (Greenberg et al.1993) and antidepressants are the cornerstone of treatment. As antidepressants usually require 3-6 weeks of use before a response occurs, an effective antidepressant acceleration strategy would reduce the time of onset for an effective antidepressant response. This has significant clinical implications, as it could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life.
The goal of this study is to enhance our understanding of strategies that accelerate or produce a more rapid treatment response in depression. This could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life.
The study goals are: 1.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can accelerate the treatment response (i.e. faster rate of improvement), 2.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can augment or enhance treatment response (i.e. greater reduction in depressive symptoms at end of study phase), adn 3.) To assess whether gender influences the acceleration of augmentation response rate of liothyronine or pindolol.
- Conditions
- Depression
- Being tested
- citalopram + tiodothyronine, or + pindolol, or + placebo
- Keywords
- depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopram + tiodothyronine, or + pindolol, or + placeboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionJun 2006
Why it stopped: PI move
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Frye
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor-investigator, Mark Frye, Mayo Clinic
- Investigators
- Mark A Frye, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221494
- Sponsor's protocol ID
- 00-09-045-11
- Status last verified
- Jun 2006
- First submitted
- 13 Sep 2005
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-blind, Placebo-controlled Randomization Research Study for Major Depression
- ClinicalTrials.gov ID
- NCT00221494
- Acronym / sponsor ID
- 00-09-045-11
- Conditions
- Depression
- Keywords
- depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI move
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mark FryeUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jan 2004
- Primary completion
- Jun 2006 (actual)
- First posted
- 22 Sep 2005 (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.
Antidepressants are commonly prescribed and are effective for treating depression. However, they generally take 4-6 weeks for a therapeutic response. This study is evaluating whether simultaneous treatment with thyroid hormone or pindolol can decrease the response time ("getting better faster") in patients who are starting SSRI treatment.
Detailed description
Major depression is an illness with substantial personal and economic morbidity (Greenberg et al.1993) and antidepressants are the cornerstone of treatment. As antidepressants usually require 3-6 weeks of use before a response occurs, an effective antidepressant acceleration strategy would reduce the time of onset for an effective antidepressant response. This has significant clinical implications, as it could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life.
The goal of this study is to enhance our understanding of strategies that accelerate or produce a more rapid treatment response in depression. This could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life.
The study goals are: 1.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can accelerate the treatment response (i.e. faster rate of improvement), 2.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can augment or enhance treatment response (i.e. greater reduction in depressive symptoms at end of study phase), adn 3.) To assess whether gender influences the acceleration of augmentation response rate of liothyronine or pindolol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients, male and female, between the ages of 18 to 65
- DSM-IV criteria for major depressive disorder
- No prior SSRI medication treatment (if a patient has discontinued a non-SSRI medication for side effects, they will not be excluded)
- Ability to be followed clinically for 6 weeks
- Each patient must understand the nature of the study and must sign an informed consent form
Key exclusion criteria (8 listed)
- Severe suicidality (as defined by Beck Depression Inventory Question 9, responses 2 or 3)
- Major Axis I mental illness other than major depressive disorder
- Unstable medical health specifically cardiovascular disease, abnormal EKG, history of severe drug allergy, poorly controlled diabetes, and asthma (pindolol contraindication)
- History of thyroid disease or abnormal TFT's (stage I or II)
- Need for adjunctive antipsychotic use or additional benzodiazepine during the study
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 |
|---|---|---|
| citalopram + tiodothyronine, or + pindolol, or + placebo | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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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.
Mark A Frye, MD principal investigator
University of California, Los Angeles
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 of Depression, run by Mark Frye 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Jun 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 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 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 was withdrawn before enrolling participants, so there are no results.
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.
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 1 Jun 2015.