N/A
Completed N=344
Identifying Factors That Predict Antidepressant Treatment Response
Source: ClinicalTrials.gov NCT00360399 ↗Enrolled (actual)
344
Serious AEs
2.9%
Results posted
Jul 2016
Primary outcomePrimary: Remission From Major Depressive Episode in Intent to Treat Sample — 46.7; 54.7; 41.9 percentage of participants
Summary
This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission From Major Depressive Episode in Intent to Treat Sample |
46.7; 54.7; 41.9 | — |
| PRIMARY Remission From Major Depressive Episode Among Participants Who Completed the Intervention |
44.2; 51.9; 43.5 | — |
| SECONDARY Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample |
26; 21; 32; 12; 16; 19 | — |
| SECONDARY Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention |
15; 10; 15; 10; 12; 13 | — |
| SECONDARY Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment |
0; 0; 1; 1; 2; 1 | — |
| SECONDARY Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy |
22; 10; 18 | — |
Eligibility Criteria
Inclusion Criteria
- Current DSM-IV diagnosis of major depressive episode, as determined by Structured Clinical Interview for DSM-IV (SCID-IV)
- Primary diagnosis of MDD, based on prominence of symptoms and target for intervention (comorbid anxiety disorders, except obsessive-compulsive disorder (OCD), will not be criteria for exclusion)
- Score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
- Agrees to use an effective form of contraception and/or double barrier method
Exclusion Criteria
- Previously treated for major depression with either medication or psychotherapy
- Current psychosis, dementia, eating disorder, or dissociative disorder
- History of bipolar disorder (I and II) or schizophrenia
- Alcohol or drug dependence within 3 months prior to study entry or current alcohol or drug abuse (excluding nicotine and caffeine), as assessed by medical history and urine drug screening
- Requires neuroleptic or mood stabilizer therapy in addition to depression treatment
- Presence of any acute or chronic medical disorder that could affect successful completion of the trial
- Medical contraindications that would preclude treatment with escitalopram or duloxetine
- Presence of practical issues that would likely prevent completion of the study (e.g., planned geographical relocation)
- Pregnant or breastfeeding
- Medical conditions that could prevent the safe use of MRI (e.g., pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, or other implants; steel worker)
- Medical conditions that could prevent the safe completion of a dexamethasone-corticotropin releasing factor (Dex-CRF) test (e.g., uncontrolled hypertension, significant abnormalities in EKG, anemia, known allergies against drugs)
Data sourced from ClinicalTrials.gov (NCT00360399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.