Flexible Dose Titration Add-on Study to Treat Major Depressive Disorder

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Targacept Inc.
• Treatments: Mecamylamine

Criteria

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.