DepressionNCT00108316
Determinants in Antidepressant Outcomes
A study testing Fluoxetine (Liquid Prozac) in people with Depression, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study is designed to understand if a biological measurement, of how platelets respond to serotonin (a chemical in the blood sometimes referred to as SERT), can provide information that will determine an "ideal dose," one specifically tailored for each individual's chemistry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Fluoxetine (Liquid Prozac)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Sep 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A current episode satisfying DSM-IV criteria for Major Depressive Disorder (except controls).
- No psychotropic medication during the previous 2 weeks before baseline (no SSRIs or SNRIs for previous 3 months).
- A current depression score of 20 or greater on the 24-item Hamilton Depression Scale (patients).
- Willingness and ability to give informed consent.
- Age 18 and up.
Who cannot join
- Cardiovascular disease; subjects w/ myocardial infarcts within the past 3 months, heart failure, or other evidence of compromised cardiac function
- Uncontrolled hypertension: systolic blood pressure > 160, or diastolic > 95
- Previously noted thyroid disease, unless clinically euthyroid for 2 or more months.
- Endocrine disease or exogenous hormones except HRT for postmenopausal women.
- Women not using an effective method of birth control (barrier method, oral contraceptives and/or IUD), pregnant or lactating women.
- Women with menometrorrhagia, premenstrual dysphoric disorder (PMDD), or premenopausal hysterectomized women with intact ovaries, or without HRT.
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- Subjects who require concomitant psychotropic medications. Psychotropic medication during the previous 2 weeks before baseline, 3 months for SSRIs or SNRIs, or 4 months for depot neuroleptics.
- Evidence of clinically significant gastrointestinal, hepatic, renal, endocrine, ophthalmologic, neurologic, cardiovascular or hematological disease including anemia, hemophilia, or significant liver disease.
- History of intolerable side effects to the proposed treatment.
- Patients who have ever met DSM-IV criteria for any psychosis, schizophrenia, bipolar disorder, organic brain syndrome or any other primary Axis I major psychiatric disorder other than major depression. Controls must be without past history of depression.
- Patients who meet DSM-IV criteria for any substance abuse during the past 2 months or dependence during the last 6 months, including positive urine drug screens.
- History of priapism
- Subjects who are starting a new psychotherapy program during the 16 weeks of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SERT Affinity Determinants in Antidepressant Outcomes
This study is designed to understand if a biological measurement, of how platelets respond to serotonin (a chemical in the blood sometimes referred to as SERT), can provide information that will determine an "ideal dose," one specifically tailored for each individual's chemistry. The biological measurement will be obtained by testing a blood sample. There will be approximately 120 control subjects expected for enrollment.
Read the detailed description
OBJECTIVE: The objective of this dose-ranging three-arm study of fluoxetine is to study the kinetics of the serotonin transporter in platelets and relate this to antidepressant response by comparing the manipulation of serotonin and platelet measure to standard treatment as it now exists.
RESEARCH PLAN: The project will examine two methods of dose adjustment of selective serotonin reuptake inhibitor (SSRI) treatment: The first method emulates the current standard clinical practice, i.e., titrating the dosage based upon the subject's current depression symptomatology (standard treatment arm). The second method utilizes the measurement of the Km to create a dosage tailored to the individual to approach the optimum treatment Kapp (biological treatment arm). Additionally, the placebo arm will control for treatment failure and high placebo response. This application is a double-blind, placebo controlled, randomized, dose ranging study in male and female outpatients with Major Depressive Disorder. The proposed study will take place over a period of 12 weeks recruiting 117 subjects (in order to achieve 90 completers, 30 in each arm, assuming 30% dropout rate) over a five year period who are diagnosed with Major Depression according to DSM-IV criteria. Following a 1 week screening period during which safety assessments are completed and evaluated and the Km and dosage are calculated, the subjects will be blindly randomized in a 1:1:1 ratio to either the standard treatment, the biological arm or the placebo arm. Subjects will return to the clinic at weeks 4, 8, and 12 for ratings and platelet Km determinations. Response will be measured and dosage adjustment will be made at weeks 4 and 8. A final determination of response will be made at week 12.
METHODS: Responders will be identified according to conventional criteria will be defined as those subject who 1) have a 50% or more improvement from baseline scores, as measured on the Hamilton Depression Scale (HAM-D), 2) no longer meet Major Depressive criteria according to DSM-IV; and 3) score < 10 on the HAM-D 17 item or <15 on the 24-item HAM-D. The efficacy measures will be the Hamilton Depression Scale (HAM-D): The seventeen item scale is designed to measure depression level; Montgomery-Asberg Depression Rating Scale (MADRS): A scale designed to provide additional subjective information to determine depressive symptoms; The Profile of Mood States (POMS) and the Cloninger Temperament Character Index (TCI) are patient rated scales which measure feelings and personality traits. The safety parameters include physical examinations, vital signs, collection of adverse events, and 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
CLINICAL RELEVANCE: Previous studies have indicated fluoxetine is an effective treatment for depression. This study is designed to provide additional information concerning the methods for determining dose. Potentially, the information gained from this research may provide a more cost-effective way of finding an effective dose than the trial and error approach generally used.
- Conditions
- Depression
- Being tested
- Fluoxetine (Liquid Prozac)
- Keywords
- Depressive Disorder, DNA, Serotonin
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxetine (Liquid Prozac)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Drug: Fluoxetine (Liquid Prozac) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study startJan 2004
- Primary completionSep 2005
- Study completionSep 2005
Why it stopped: Study PI resigned
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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffrey Rausch, MD, Principal investigator, VA Medical Center, Augusta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108316
- Sponsor's protocol ID
- MHBS-003-02S
- Status last verified
- Sep 2013
- First submitted
- 14 Apr 2005
- Last updated
- 27 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SERT Affinity Determinants in Antidepressant Outcomes
- ClinicalTrials.gov ID
- NCT00108316
- Acronym / sponsor ID
- MHBS-003-02S
- Conditions
- Depression
- Keywords
- Depressive Disorder, DNA, Serotonin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study PI resigned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 15 Apr 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.
This study is designed to understand if a biological measurement, of how platelets respond to serotonin (a chemical in the blood sometimes referred to as SERT), can provide information that will determine an "ideal dose," one specifically tailored for each individual's chemistry. The biological measurement will be obtained by testing a blood sample. There will be approximately 120 control subjects expected for enrollment.
Detailed description
OBJECTIVE: The objective of this dose-ranging three-arm study of fluoxetine is to study the kinetics of the serotonin transporter in platelets and relate this to antidepressant response by comparing the manipulation of serotonin and platelet measure to standard treatment as it now exists.
RESEARCH PLAN: The project will examine two methods of dose adjustment of selective serotonin reuptake inhibitor (SSRI) treatment: The first method emulates the current standard clinical practice, i.e., titrating the dosage based upon the subject's current depression symptomatology (standard treatment arm). The second method utilizes the measurement of the Km to create a dosage tailored to the individual to approach the optimum treatment Kapp (biological treatment arm). Additionally, the placebo arm will control for treatment failure and high placebo response. This application is a double-blind, placebo controlled, randomized, dose ranging study in male and female outpatients with Major Depressive Disorder. The proposed study will take place over a period of 12 weeks recruiting 117 subjects (in order to achieve 90 completers, 30 in each arm, assuming 30% dropout rate) over a five year period who are diagnosed with Major Depression according to DSM-IV criteria. Following a 1 week screening period during which safety assessments are completed and evaluated and the Km and dosage are calculated, the subjects will be blindly randomized in a 1:1:1 ratio to either the standard treatment, the biological arm or the placebo arm. Subjects will return to the clinic at weeks 4, 8, and 12 for ratings and platelet Km determinations. Response will be measured and dosage adjustment will be made at weeks 4 and 8. A final determination of response will be made at week 12.
METHODS: Responders will be identified according to conventional criteria will be defined as those subject who 1) have a 50% or more improvement from baseline scores, as measured on the Hamilton Depression Scale (HAM-D), 2) no longer meet Major Depressive criteria according to DSM-IV; and 3) score < 10 on the HAM-D 17 item or <15 on the 24-item HAM-D. The efficacy measures will be the Hamilton Depression Scale (HAM-D): The seventeen item scale is designed to measure depression level; Montgomery-Asberg Depression Rating Scale (MADRS): A scale designed to provide additional subjective information to determine depressive symptoms; The Profile of Mood States (POMS) and the Cloninger Temperament Character Index (TCI) are patient rated scales which measure feelings and personality traits. The safety parameters include physical examinations, vital signs, collection of adverse events, and 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
CLINICAL RELEVANCE: Previous studies have indicated fluoxetine is an effective treatment for depression. This study is designed to provide additional information concerning the methods for determining dose. Potentially, the information gained from this research may provide a more cost-effective way of finding an effective dose than the trial and error approach generally used.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Fluoxetine (Liquid Prozac) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A current episode satisfying DSM-IV criteria for Major Depressive Disorder (except controls).
- No psychotropic medication during the previous 2 weeks before baseline (no SSRIs or SNRIs for previous 3 months).
- A current depression score of 20 or greater on the 24-item Hamilton Depression Scale (patients).
- Willingness and ability to give informed consent.
- Age 18 and up.
Key exclusion criteria (13 listed)
- Cardiovascular disease; subjects w/ myocardial infarcts within the past 3 months, heart failure, or other evidence of compromised cardiac function
- Uncontrolled hypertension: systolic blood pressure > 160, or diastolic > 95
- Previously noted thyroid disease, unless clinically euthyroid for 2 or more months.
- Endocrine disease or exogenous hormones except HRT for postmenopausal women.
- Women not using an effective method of birth control (barrier method, oral contraceptives and/or IUD), pregnant or lactating women.
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 |
|---|---|---|
| Fluoxetine (Liquid Prozac) | Drug | Arm 1 |
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 27 Sep 2013.
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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.
Jeffrey Rausch, MD principal investigator
VA Medical Center, Augusta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine (Liquid Prozac) in people with Depression, run by US Department of Veterans Affairs 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 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: withdrawn, as of the sponsor's last update on 27 Sep 2013. 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.
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 27 Sep 2013.