Risperidone vs. Olanzapine as add-on Treatment in Treatment Resistant Depression

This is an interventional treatment trial for Subjects Had Unipolar, Non-psychotic Major Depression focused on measuring depression, treatment resistant depression, unipolar, non- psychotic major depression, add-on to a serotonin type antidepressants, risperidone, olanzapine, double blind comparison, randomized Read More

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.