| Eligibility |
Recruitment by invitation only
Inclusion Criteria:
- Outpatients with nonpsychotic MDD. Outpatient status assumes that the subject is not
psychiatrically hospitalized or in an active suicidal crisis requiring
hospitalization.
- A total score of >10 on the QIDS-CR and on the QIDS-SR (equivalent to a HAMD17 score
of 13 [ids-qids.org, accessed on April 12, 2019]) given that when medication exceeds
the effect of placebo in primary care, participants have a 17-item HAMD score >12. We
added 2 HAMD points to take into account the possibility of measurement error. This is
a very similar approach taken to the successful recruitment of subjects into the
PGRN-AMPS trial.
- Antidepressant treatment is deemed appropriate by the study clinician.
- Adults who are between 18-64 years of age.
- Ability to provide informed consent
- Ability to understand English
Exclusion Criteria:
- A medical contraindication that precludes SSRI or SNRI treatment.
- Presence of a general medical condition that, in the opinion of this study clinician,
is the cause of their depressive symptoms, will be exclusionary.
- People with treatment-resistant depression will be excluded from participating. For
this study, treatment resistance will be defined as failure to respond to two or more
adequate therapeutic trials of SSRIs and at least on SNRI therapeutic trial
(sufficient antidepressant dose, for 6 weeks or longer) during the current depressive
episode. Failure to tolerate a therapeutic trial of a given medication (resulting in
discontinuation due to adverse effects) will not be counted as exclusionary. Persons
who have failed to respond to two or more adequately designed and executed therapeutic
trials of SSRIs but have no history of least one failure to respond to SNRI treatment
during the current depressive episode will be eligible to receive treatment with an
SNRI in this study.
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar I or II disorder, or
bipolar disorder NOS (including other specified or other unspecified bipolar
disorders) or a primary psychiatric condition that requires a different initial
treatment than an antidepressant.
- Currently taking an antidepressant medication with subtherapeutic results in terms of
antidepressive efficacy and unwilling to undergo a medication taper and
discontinuation prior to initiation of a study drug from this protocol. The subject
will be closely monitored by the study clinician during the medication taper and
discontinuation phase. The design of the medication taper will be at the discretion of
the study clinician. Subjects who cannot be safely tapered from their medication or
who experience adverse effects during the taper that make further tapering infeasible
will be excluded from the study.
- Use of antidepressant medication primarily for management of nicotine dependence,
chronic pain, migraine prophylaxis or other diagnoses.
- Active substance use disorder. Persons in sustained full remission (> 12 months) and a
negative urine drug of abuse screen at the screening visit will be considered
eligible. Note: An additional urine drug screen will not be necessary for individuals
with a negative urine drug screen documented in the medical record where the date of
testing occurred within 12 weeks (84 days) of the screening/baseline study visit.
However, study clinicians can still obtain a urine drug screen based on their clinical
judgement even in participants with a negative drug screen within the 12 weeks
preceding the screening/baseline study visit.
- Trazodone, melatonin, low-dose quetiapine (<100 mg QHS), z-drugs (zolpidem, zopiclone,
eszopiclone, etc.), ramelteon, and diphenhydramine may be used as rescue medications
for insomnia. Benzodiazepines may be used for treatment of anxiety, and atomoxetine
may be used for the treatment of attention deficit disorder. Study subjects currently
on antipsychotic medications (e.g., typical and atypical antipsychotic drugs, other
than low-dose quetiapine for insomnia) and mood stabilizing agents (e.g., lithium,
carbamazepine, valproate, lamotrigine) are not eligible for the study
- Pregnant subjects and those who are currently breastfeeding and who plan to continue
breastfeeding will be excluded.
- Persons currently undergoing ECT, TMS or DBS as acute series or for maintenance.
- Patients currently psychiatrically hospitalized or in an active suicidal crisis
requiring hospitalization in the opinion of the study clinician.
- Individuals whose total QIDS-CR and total QIDS-SR scores are 10 or higher at the
screening visit but decrease (improve) to total scores less than 10 on either the
QIDS-CR or QIDS-SR at the baseline visit
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