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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT01022632
Eligibility Criteria:
Inclusion Criteria:
* Depression as diagnosed under DSM-IV Axis I Disorders.
* Score greater than 7 but less then 35 on the 17-item Hamilton Depression (HAM-D) Scale at screening.
* The patient has relative(s) to care for him/her
* Informed consent obtained from the patient or relative
Exclusion Criteria:
* Scores greater than 2 on the "suicide" item of HAM-D, or history of suicide attempt(s) in the past 12 months.
* Current suicidal or homicidal risk, as determined by the investigator.
* Clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal.
* History of seizure disorder (other than febrile).
* Patient who has had monoamine oxidase inhibitor , any selective serotonin reuptake inhibitor or any other antidepressant in last 15 days
* Any of the following DSM-IV diagnoses current (within past 3 months) schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent)
* Patient with history of untreated or unstable thyroid disorder
* Failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or MAOI equivalent, or greater than or equal to 100 mg of sertraline, or its SSRI equivalent.
* Have had other investigational drugs within 30 days or other psychotropic medication within 21 days.
* Known allergy or hypersensitivity to the study medications.
* Receiving psychotherapies which are specifically designed to treat depression, eg, interpersonal psychotherapy during the study period.
* Mental retardation or cognitive impairment, or any disorder that might interfere with their ability to give consent or follow study procedures and requirements.
* In case of female patients, Abstinence or effective method of contraception throughout the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01022632
Study Brief:
Protocol Section:
NCT01022632