Major Depressive Disorder Clinical Trial
Official title:
A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of Mecamylamine 5.0 to 10 mg, in the Treatment of Major Depressive Disorder With Subjects Who Are Partial or Non- Responders to Citalopram Therapy.
Verified date | January 2008 |
Source | Targacept Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Depressed patients will receive 6 weeks of citaloprma (20-40mg) therapy. Subjects who have an inadequate response (partial or non-responder) will be randomized to receive either mecamylamine (5-10mg) or placebo added to their citalopram for a further 8 weeks.
Status | Completed |
Enrollment | 450 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: (A) Open Phase - Male or female subjects aged 18-70 years. - Diagnosis of major depressive disorder (MDD) according to DSM-IV and confirmed via MINI diagnostic scale. - Able to give written informed consent. - HAMD-17 score greater than 21. - CGI-Severity of Illness score greater than or equal to 4. - No clinically significant abnormality on physical examination, vital signs, ECG or laboratory tests (biochemical, hematological, urinary) at screening. - Women of child bearing potential with a negative urine pregnancy test and willing to use acceptable methods of contraception. (B)Double Blind Phase: - Subjects still to meet DSM-IV criteria for MDD. - Subjects continue to meet all of the inclusion and exclusion criteria. - HAMD-17 score greater than or equal to 14. - CGI severity of illness score greater than or equal to 4. - Women of child bearing potential with a negative urine pregnancy test and willing to use acceptable methods of contraception. Exclusion Criteria: - Aged below 18 years and above 70 years. - Failure to meet DSM IV criteria for MDD. - HAMD-17 less than or equal to 21 (open-label phase only). - CGI Severity of Illness score less than 4. - Clinically significant changes in physical examination, vital signs, ECG or laboratory tests at screening. - Any other co morbid psychiatric illness confirmed by MINI diagnostic scale, especially bi-polar disorder, schizophrenia or dementia. - Subjects with significant suicidal risk upon clinical assessment. - Subjects who have treatment resistant depression i.e. who have failed adequate course (daily dose and duration of treatment) of one or more antidepressants. - History of alcohol or drug abuse over the last 6 months. - History of seizures or seizure disorders. - Seropositive for HIV or hepatitis B (antibody or antigen). - Any other severe progressive and uncontrolled medical condition. - For controlled other medical conditions, medication to be unchanged over the 2 months preceding screening, or else the patient will be excluded. - Subjects with Glaucoma, Kidney Disease or Heart Disease. - Known hypersensitivity to mecamylamine. - Women of child bearing potential not taking adequate contraception and women breastfeeding. - Other investigational drug in previous 30 days. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Targacept Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HAMD-17 group mean change from baseline to endpoint and/or the proportion of subjects considered to be full responders or in remission with a HAMD-17 score less than or equal to 7 at the end of treatment. | 8 weeks | No | |
Secondary | Montgomery Asbery depression rating sclae, Clinical Global Impression Scale - Severity, Clinical Global Impression Sacle - Change, Sheehan irritability scale, Sheehan disability scale | 8 weeks | No | |
Secondary | Blood biochemistry, urnie analysis, blood pressure, heart rate, ECG | 8 weeks | Yes | |
Secondary | Citalopram plasma bloods at week 6 and 14. | 8 weeks | No |
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