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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT01282632
Eligibility Criteria:
Inclusion Criteria:
Subjects who meet all of the following criteria are eligible for this trial:
1. Male or female out-patients;
2. Aged between 18 and 65 years (extremes included);
3. Subjects suffering from a current episode of non-psychotic, unipolar depression as determined by the depression section of the SCID-IV.
4. Subjects with treatment resistant depression defined as failure to respond to two successive courses of monotherapy given in adequate doses for a minimum of 4 weeks with different antidepressants (the current course of antidepressant can be considered to second failed course) and;
5. Subjects currently taking a SSRI or a SNRI for at least 4 weeks, at adequate dosage and not responding, as defined by a score of 3 or more on the CGI-I. and no dose change for 2 weeks prior to entry.
6. A minimum score of 16 on the 17 item HAM-D
7. Ability to provide informed consent.
Exclusion Criteria:
Subjects meeting one or more of the following criteria cannot be selected:
1. Subjects who are actively suicidal as determined by a score of 3 on the suicide item on the HAM-D or in the opinion of the treating physician;
2. Other current (active symptomatology within the last 2 months) Axis I DSM IV diagnosis other than nicotine or caffeine dependence or other than an Anxiety disorder.
3. Use of disallowed concomitant therapy; or other psychotropic medication except occasional benzodiazepines. (See "Rescue Medication");
4. History of alcohol or drug abuse or dependence, within 3 months of entry into the trial);
5. Seizure disorder requiring medication;
6. Active medical condition that requires urgent attention or that would contra-indicate the use of risperidone or olanzapine. For example stable thyroid disease or asthma would be acceptable, whereas acute hepatitis would not;
7. Participation in an investigational drug trial within 30 days prior to the start of the trial
8. Known sensitivity to risperidone, olanzapine or the antidepressant;
9. History of neuroleptic malignant syndrome (NMS);
10. Subjects who are at imminent risk of injury to self or others, or causing significant damage to property, as judged by the investigator;
11. Female subjects who are pregnant or breast-feeding;
12. Female subject of childbearing potential without adequate contraception (sterilization, barrier, IUD, oral contraceptives, intramuscular or subdermal administration of depot-progestagens);
15\. Previous exposure to risperidone or olanzapine during the current episode.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01282632
Study Brief:
Protocol Section:
NCT01282632