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 @ 1:56 PM
Ignite Modification Date:
2025-12-24 @ 1:56 PM
NCT ID:
NCT01948895
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients between 18-65 years.
* Primary diagnosis of Dysthymic Disorder, as defined by DSM-IV criteria (300.4).
* MADRS score ≥15 at Screening and Baseline.
* Supportive therapy, and use of zopiclone for sleep and low-dose benzodiazepines on an as needed basis for anxiety, is allowed at any time.
* Written informed consent
Exclusion Criteria:
* Co-morbid diagnosis of any other Axis I disorders (other than anxiety disorders such as Generalized Anxiety Disorder, Social Anxiety Disorder and Post-traumatic Stress Disorder, provided that Dysthymic Disorder is currently the diagnosis).
* Meet DSM-IV criteria for a current episode of major depression within two months prior to screening or who have received treatment for a major depressive episode within six months prior to screening.
* Substance abuse or dependence including alcohol, within 6 months prior to screening.
* Patients on the following prohibited treatments:
1. Psychotropics such as other SSRIs, other SNRIs, lithium, sibutramine, tramadol, St. John's Wort, within 2 weeks of randomization
2. Agents that impact significantly on serotonin metabolism (e.g. MAOIs, tryptophan, triptans) within 2 weeks of randomization
* Have received physical therapies for depression (e.g. ECT, rTMS) within the 3 months prior to randomization.
* Previous non-response to a therapeutic trial of desvenlafaxine (at least 50 mg/day for 2 months).
* Clinically significant abnormalities in hematology, clinical chemistry, urinalysis or ECG at the screening visit, as judged by the Principal Investigator.
* Presence of medical or psychiatric condition deemed by the Investigator to interfere with study procedures or endpoint data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01948895
Study Brief:
Protocol Section:
NCT01948895