Biomarkers of Antidepressant Treatment in Adolescents With Major Depression (The Adolescents MDD Study)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01185977
• Date of registration: 06/04/2010
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Biomarkers of Antidepressant Treatment in Adolescents With Major Depression (The Adolescents MDD Study)
• Scientific title: Biomarkers of Antidepressant Treatment in Adolescents With Major Depression
• Date of first enrolment: April 2010
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01185977
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Ian A Cook, MD
• Affiliation: Universityof California Los Angeles

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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:

1. mentally or legally incapacitated, unable to give informed consent;

2. 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;

3. MMSE (Folstein et al., 1975) score = 24;

4. evidence of drug dependency or substance abuse within the preceding nine months;

5. stable and in remission on current psychotropic medication(s);

6. any ECT within the past six months;

7. failure to tolerate FLX or treatment failure with an adequate trial of FLX in
the current episode;

8. FLX would be contraindicated (e.g., hyponatremia with a prior SSRI);

9. treatment with an MAOI within the past four weeks;

10. any medical illness severe enough to significantly affect brain function or to
interfere with interpretation of study results;

11. history of seizures, brain surgery, skull fracture, significant head trauma, or
abnormal EEG;

12. psychiatric hospitalization indicated (e.g., imminent danger to self or others);

13. initial QEEG recording is contaminated with artifact so that determination of
the biomarker is precluded;

14. 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);

15. 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).



Age minimum: 14 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: Placebo

Drug: Fluoxetine

Primary Outcome(s)

Score on Children's Depression Rating Scale-Revised [Time Frame: Measured over 8 weeks]

Secondary Outcome(s)

Score on Hamilton Depression Rating Scale (HAM-D) [Time Frame: Measured over 8 weeks]

Secondary ID(s)

090713201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors