Major Depressive DisorderPhase 4NCT01185977
Biomarkers of Antidepressant Treatment in Adolescents With Major Depression (The Adolescents MDD Study)
A Phase 4 study testing Fluoxetine in people with Major Depressive Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will aim to evaluate the use of Electroencephalography (EEG) biomarkers in adolescent depression. Two specific hypotheses will be tested: H1: Early decreases in prefrontal cordance values will be greater in responders to antidepressant therapy than in medication non-responders. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2011
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) based on the K-SADS-PL
- A score of ≥ 45 on the Children's Depression Rating Scale-Revised (same threshold as TADS). As with the TADS trial, depressed mood must have been present in at least 2 of 3 contexts (home, school, among peers) for at least 6 weeks prior to consent.
- Age range: 14-18.
- Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.
Who cannot join
- Subjects will have no unstable medical illness that would prevent completion of participation in the trial (determined as needed from physical examination, ECG, laboratory safety tests, as well as a review of systems). Other specific exclusionary criteria also are based on the BRITE-MD parameters, and include:
- mentally or legally incapacitated, unable to give informed consent;
- meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major depression with psychotic features;
- MMSE (Folstein et al., 1975) score ≤ 24;
- evidence of drug dependency or substance abuse within the preceding nine months;
- stable and in remission on current psychotropic medication(s);
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- any ECT within the past six months;
- failure to tolerate FLX or treatment failure with an adequate trial of FLX in the current episode;
- FLX would be contraindicated (e.g., hyponatremia with a prior SSRI);
- treatment with an MAOI within the past four weeks;
- any medical illness severe enough to significantly affect brain function or to interfere with interpretation of study results;
- history of seizures, brain surgery, skull fracture, significant head trauma, or abnormal EEG;
- psychiatric hospitalization indicated (e.g., imminent danger to self or others);
- initial QEEG recording is contaminated with artifact so that determination of the biomarker is precluded;
- use of medications known to affect brain function (e.g., antidepressants, anticonvulsants/mood stabilizers, anticholinergics, antipsychotics, benzodiazepines - same list as in BRITE-MD). Based on the TADS trial, we will also exclude for concurrent diagnoses of attention-deficit hyperactivity disorder managed with psychostimulants, pervasive developmental disorder, and mental retardation (mild, moderate, severe, or profound);
- subject is currently pregnant, or is of child-bearing potential and not using a medically acceptable means of birth control (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers of Antidepressant Treatment in Adolescents With Major Depression
This study will aim to evaluate the use of Electroencephalography (EEG) biomarkers in adolescent depression. Two specific hypotheses will be tested:
H1: Early decreases in prefrontal cordance values will be greater in responders to antidepressant therapy than in medication non-responders.
H2: Subjects with high Antidepressant Treatment Response(ATR) Index values [i.e., predicted to show symptomatic improvement with fluoxetine (FLX)] will achieve greater improvement in symptoms and in functional status than those with low ATR values.
Exploratory analyses will be undertaken to compare and contrast the cordance changes and ATR values in medication and placebo-treated responders and non-responders.
Read the detailed description
A total of 26 adolescent subjects with Major Depressive Disorder(MDD), ages 12 to 20, will be consented and join this project at UCLA. For analytic purposes, we will define an "enrolled" subject as one who has completed the single-blind lead-in week and one week of double-blind treatment, and the three EEG recordings at these visits, as any subject who leaves the project prior to that point cannot contribute useful data to testing our hypotheses.
Subjects who enroll in this project will receive 1 week of single-blind placebo lead-in, followed by 8 weeks of double-blind randomized treatment either with fluoxetine (FLX), a Selective Serotonin Reuptake Inhibitor (SSRI) with FDA approval for use in this age group, or with placebo. Brain activity will be assessed with Qualitative EEG (QEEG) recording at pretreatment baseline, after lead-in, and at 1, 2, 4, and 8 weeks of treatment to expand the evidence base on the neurophysiology of treatment response in adolescents. Subjects will be assessed for symptom change, adverse events, and suicidality at each visit. Functional measures related to treatment will be assessed at baseline and at weeks 4 and 8. Subjects and the staff who interact with them will be blinded to QEEG biomarker values during the project.
- Conditions
- Major Depressive Disorder
- Being tested
- Fluoxetine, Placebo
- Keywords
- Major Depressive Disorder, Fluoxetine, QEEG, cordance, ATR
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
one-week single-blind PBO-lead-in phase, FLX 10 mg/d for 4 days then 20 mg/d of FLX thereafter
PlaceboDrug
One pill of PBO for 4 days then two pills of PBO thereafter
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Active comparator | 1 week single-blinded placebo lead-in and double-blinded FLX treatment for 8 weeks Receives: Drug: Fluoxetine |
| Placebo (PBO) | Placebo comparator | Placebo treatment for 9 weeks of study Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Children's Depression Rating Scale-Revised
Measured: Measured over 8 weeks
Secondary outcomes (1)
Score on Hamilton Depression Rating Scale (HAM-D)
Measured: Measured over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian A. Cook, M.D., University of California, Los Angeles
- Investigators
- Ian A Cook, MD, Principal investigator, Universityof California Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185977
- Sponsor's protocol ID
- 090713201
- Status last verified
- Jul 2014
- First submitted
- 6 Apr 2010
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Antidepressant Treatment in Adolescents With Major Depression
- ClinicalTrials.gov ID
- NCT01185977
- Acronym / sponsor ID
- 090713201
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Fluoxetine, QEEG, cordance, ATR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- First posted
- 20 Aug 2010 (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 will aim to evaluate the use of Electroencephalography (EEG) biomarkers in adolescent depression. Two specific hypotheses will be tested:
H1: Early decreases in prefrontal cordance values will be greater in responders to antidepressant therapy than in medication non-responders.
H2: Subjects with high Antidepressant Treatment Response(ATR) Index values [i.e., predicted to show symptomatic improvement with fluoxetine (FLX)] will achieve greater improvement in symptoms and in functional status than those with low ATR values.
Exploratory analyses will be undertaken to compare and contrast the cordance changes and ATR values in medication and placebo-treated responders and non-responders.
Detailed description
A total of 26 adolescent subjects with Major Depressive Disorder(MDD), ages 12 to 20, will be consented and join this project at UCLA. For analytic purposes, we will define an "enrolled" subject as one who has completed the single-blind lead-in week and one week of double-blind treatment, and the three EEG recordings at these visits, as any subject who leaves the project prior to that point cannot contribute useful data to testing our hypotheses.
Subjects who enroll in this project will receive 1 week of single-blind placebo lead-in, followed by 8 weeks of double-blind randomized treatment either with fluoxetine (FLX), a Selective Serotonin Reuptake Inhibitor (SSRI) with FDA approval for use in this age group, or with placebo. Brain activity will be assessed with Qualitative EEG (QEEG) recording at pretreatment baseline, after lead-in, and at 1, 2, 4, and 8 weeks of treatment to expand the evidence base on the neurophysiology of treatment response in adolescents. Subjects will be assessed for symptom change, adverse events, and suicidality at each visit. Functional measures related to treatment will be assessed at baseline and at weeks 4 and 8. Subjects and the staff who interact with them will be blinded to QEEG biomarker values during the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Active comparator | Drug: Fluoxetine1 week single-blinded placebo lead-in and double-blinded FLX treatment for 8 weeks |
| Placebo (PBO) | Placebo comparator | Drug: PlaceboPlacebo treatment for 9 weeks of study |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) based on the K-SADS-PL
- A score of ≥ 45 on the Children's Depression Rating Scale-Revised (same threshold as TADS). As with the TADS trial, depressed mood must have been present in at least 2 of 3 contexts (home, school, among peers) for at least 6 weeks prior to consent.
- Age range: 14-18.
- Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.
Key exclusion criteria (16 listed)
- Subjects will have no unstable medical illness that would prevent completion of participation in the trial (determined as needed from physical examination, ECG, laboratory safety tests, as well as a review of systems). Other specific exclusionary criteria also are based on the BRITE-MD parameters, and include:
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 |
|---|---|---|
| Fluoxetineone-week single-blind PBO-lead-in phase, FLX 10 mg/d for 4 days then 20 mg/d of FLX thereafter | Drug | Fluoxetine |
| PlaceboOne pill of PBO for 4 days then two pills of PBO thereafter | Drug | Placebo (PBO) |
Primary outcome
Score on Children's Depression Rating Scale-Revised
Time frame: Measured over 8 weeks
1 secondary outcome
Score on Hamilton Depression Rating Scale (HAM-D)
Time frame: Measured over 8 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 3 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
Ian A Cook, MD principal investigator
Universityof 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 testing Fluoxetine in people with Major Depressive Disorder, run by University of California, Los Angeles 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 4 inclusion and 16 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 3 Jul 2014. 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?
Score on Children's Depression Rating Scale-Revised (time frame: Measured over 8 weeks). 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 3 Jul 2014.