NCT00593879

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_2 major-depressive-disorder

Timeline
Completed

Started Feb 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

First QC Date

December 19, 2007

Last Update Submit

January 2, 2008

Conditions

Major Depressive Disorder

Keywords

MDDDepressionMecamylamineAdd-on TherapyMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Montgomery Asbery depression rating sclae, Clinical Global Impression Scale - Severity, Clinical Global Impression Sacle - Change, Sheehan irritability scale, Sheehan disability scale

    8 weeks

  • Blood biochemistry, urnie analysis, blood pressure, heart rate, ECG

    8 weeks

  • Citalopram plasma bloods at week 6 and 14.

    8 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Mecamylamine

2

EXPERIMENTAL
Drug: Mecamylamine

Interventions

MecamylamineDRUG

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.

Also known as: Inversine
12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • 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.
  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Mecamylamine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

NorbornanesBridged Bicyclo CompoundsBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Geoffrey C Dunbar, MD

    Targacept Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2007

First Posted

January 15, 2008

Study Start

February 1, 2005

Study Completion

August 1, 2006

Last Updated

January 15, 2008

Record last verified: 2008-01