Subjects Had Unipolar, Non-psychotic Major Depression Clinical Trial
Official title:
A Double Blind Pilot Trial to Evaluate Efficacy Trends and Safety of Risperidone and Olanzapine as add-on Therapy to Serotonin Type Antidepressants in Subjects With Treatment Resistant Depression (TRD)
Verified date | September 2010 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Janssen Ortho Canada |
Study type | Interventional |
Atypical neuroleptics may have antidepressant qualities in bipolar depression and in unipolar depression. Some data support the use of both Risperidone and Olanzapine, but there are no direct comparisons of their relative efficacy and tolerability in treatment resistant depression. The current study was designed as a pilot study to examine efficacy and tolerability of Olanzapine vs. Risperidone add on to a failed serotonin re-uptake inhibitor (SSRI) in depression.
Status | Completed |
Enrollment | 42 |
Est. completion date | March 2004 |
Est. primary completion date | March 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Hamilton Depression Rating Scale at 1 week | Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6. | day one | Yes |
Primary | Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 1 week | MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6. | day one | Yes |
Primary | Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 1 week | Impact on anxiety will be measured by the HAM-A over the 6 weeks. | day one | Yes |
Primary | Change from Baseline in Hamilton Depression Rating Scale at 2 weeks | Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6. | day 8 | Yes |
Primary | Change from Baseline in Hamilton Depression Rating Scale at 3 weeks | Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6. | day 15 | Yes |
Primary | Change from Baseline in Hamilton Depression Rating Scale at 4 weeks | Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6. | day 22 | Yes |
Primary | Change from Baseline in Hamilton Depression Rating Scale at 5 weeks | Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6. | day 29 | Yes |
Primary | Change from Baseline in Hamilton Depression Rating Scale at 6 weeks | Subject to be eligible for this trial must have a minimum score of 16 on the 17 item HAM-D which will be obtained at screening. Efficacy will be measured on the HAM-D 17 and defined as a 50% decrease from baseline to week 6. | day 43 | Yes |
Primary | Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 2 weeks | MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6. | day 8 | Yes |
Primary | Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 3 weeks | MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6. | day 15 | Yes |
Primary | Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 4 weeks | MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6. | day 22 | Yes |
Primary | Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 5 weeks | MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6. | day 29 | Yes |
Primary | Change from Baseline in Montgomery Asberg Depression Scale (MADRS)at 6 weeks | MADRS will be obtained at screening. Efficacy will be measured by the MADRS and defined as a 50% decrease from baseline to week 6. | day 43 | Yes |
Primary | Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 2 weeks | Impact on anxiety will be measured by the HAM-A over the 6 weeks. | day 8 | Yes |
Primary | Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 3 weeks | Impact on anxiety will be measured by the HAM-A over the 6 weeks. | day 15 | Yes |
Primary | Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 4 weeks | Impact on anxiety will be measured by the HAM-A over the 6 weeks. | day 15 | Yes |
Primary | Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 5 weeks | Impact on anxiety will be measured by the HAM-A over the 6 weeks. | day 22 | Yes |
Primary | Change from baseline Hamilton Rating Scale for Anxiety (HAM-A) at 6 weeks | Impact on anxiety will be measured by the HAM-A over the 6 weeks. | day 43 | Yes |
Secondary | Clinical Global Improvement Scale - Improvement | 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. | day one | Yes |
Secondary | Change from Baseline of Weight at 6 weeks | Weight (Kg) will be measured with subjects at screening then at week 6. | day 43 | No |