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Sponsored by: |
Targacept Inc. |
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Information provided by: | Targacept Inc. |
ClinicalTrials.gov Identifier: | NCT00593879 |
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.
Condition | Intervention | Phase |
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Major Depressive Disorder |
Drug: Mecamylamine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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. |
Enrollment: | 450 |
Study Start Date: | February 2005 |
Study Completion Date: | August 2006 |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo
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Drug: Mecamylamine
2.5mg mecamylamine Hcl, tablet form taken twice a day (total of 5.0mg). For 7.5 mg dose group, 2 tablets taken morning, one tablet evening. At 10.0mg, 2 tablets taken twice daily.
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2: Experimental |
Drug: Mecamylamine
2.5mg mecamylamine Hcl, tablet form taken twice a day (total of 5.0mg). For 7.5 mg dose group, 2 tablets taken morning, one tablet evening. At 10.0mg, 2 tablets taken twice daily.
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This is a double blind, randomized, placebo controlled, parallel group, flexible dose titration, add-on study. Male or female subjects aged 18-70 years suffering from Major Depressive Disorder according to DSM-IV, with a HAMD-17 score greater than 21 and a CGI-Severity of Illness score greater or equal to 4, will be started on open labeled citalopram treatment. The dose of citalopram may be increased form 20mg to 40mg over a six week period, depending on investigator assessment of tolerability and efficacy. At the end of this treatment, subjects with a HAMD-17 score greater or equal to 14 and a CGI-Severity of Illness score greater or equal to 4 will be considered as partial or non-responders and will be entered into the double blind phase of the study. Subjects will be randomized to either mecamylamine or placebo for a further 8 weeks. Citalopram medication will remain constant while mecamylamine (or placebo) can be increased from 5.0 to 7.5 to 10.0mg based on investigator assessment of tolerability and efficacy.
Plasma samples for citalopram assay will be collected at the start and end of the double blind phase to exclude any mecamylamine effect being due to a drug:drug interaction.
Approximately 500 subjects will be entered into the open-label phase of the study and approximately 160 into the double blind phase. The study will be conducted in India and the USA.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(A) Open Phase
(B)Double Blind Phase:
Exclusion Criteria:
Responsible Party: | Targacept, Inc. ( Geoffrey Dunbar, VP Clinical Development & Regulatory Affairs ) |
Study ID Numbers: | TC-5231-023-CRD-003 |
Study First Received: | December 19, 2007 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00593879 |
Health Authority: | United States: Food and Drug Administration |
MDD Depression Mecamylamine Add-on Therapy Major Depressive Disorder |
Depression Mental Disorders Mood Disorders Mecamylamine Depressive Disorder, Major |
Dexetimide Depressive Disorder Citalopram Behavioral Symptoms |
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