Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT00247195
Eligibility Criteria:
Inclusion Criteria:
PHASE 1 FOCUS GROUP 1:
* Self-identifies as Hispanic
* Screened positive for MDD during the previous study (WH-PCDP), but was unable to participate in that study due to ongoing depression treatment at the time
* Spanish-speaking
PHASE 1 FOCUS GROUP 2:
* Self-identifies as Hispanic
* Family member of a patient with MDD who participated in the previous study (WH-PCDP)
* Spanish-speaking
PHASES 1-3:
Pre-Engagement Phase
* Self-identifies as Hispanic
* Spanish-speaking
* Positive screen for MDD on the Patient Health Questionnaire (PHQ) and a preliminary diagnosis of MDD from the primary care physician during a standard medical interview
Treatment Phase
* Meets DSM-IV criteria for MDD
* Score of at least 16 on the Hamilton Depression Scale (HAM-D17) at the time of study entry
* Willing to abstain from any other type of specialized mental health services for the duration of the treatment (participants in general health care or participating in folk/spiritual healing practices are expected to continue these during the study)
* Ability to tolerate a drug-free period (2 weeks for most medications; 4 weeks for fluoxetine) if on an ineffective psychotropic medication; if current medication is effective, participants will not be asked to discontinue it (zolpidem for insomnia is also a permitted medication)
* Agrees to use an effective form of contraception for the duration of the study
Exclusion Criteria
PHASE 1 FOCUS GROUP 1:
* Comorbid medical or psychiatric conditions that may prevent focus group participation (e.g., substance use disorders, psychosis, unstable medical conditions)
* Active suicidal or homicidal ideation that may pose a danger to oneself or others
PHASE 1 FOCUS GROUP 2:
* Comorbid medical or psychiatric conditions that may prevent focus group participation (e.g., substance use disorders, psychosis, unstable medical conditions)
PHASES 1-3:
Pre-Engagement Phase
* Declines referral by a primary care physician to specialized mental health services
* Comorbid medical or psychiatric conditions that may prevent safe study participation (e.g., substance use disorders, psychosis, unstable medical conditions)
* Active suicidal or homicidal ideation that may pose a danger to oneself or others
Treatment Phase
* History of schizophrenia, bipolar disorder, schizoaffective disorder, depression with psychotic symptoms, or organic brain syndromes
* Clinically unstable medical disease, including glaucoma
* Blood pressure higher than 150/90
* Pregnant or breastfeeding
* Current or past history of seizure disorder (except febrile seizure in childhood)
* Meets DSM-IV criteria for alcohol or substance abuse or dependence (except nicotine) within the 6 months prior to screening
* Use of monoamine oxidase inhibitors (MAOIs) or fluoxetine within 4 weeks prior to screening, or use of other selective serotonin reuptake inhibitors (SSRIs), antidepressants, neuroleptics, mood stabilizers, buspirone, benzodiazepines, or other psychotropic drugs, except zolpidem for insomnia within 2 weeks prior to screening
* Currently receiving formal psychotherapy from a mental health provider, whether or not the focus of the therapy is MDD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00247195
Study Brief:
Protocol Section:
NCT00247195