NCT00255918

Brief Summary

This study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in producing beneficial effects similar to that of nicotine in individuals with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Mar 2004

Typical duration for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

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

March 1, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

November 16, 2005

Last Update Submit

June 30, 2015

Conditions

SchizophreniaPsychotic Disorders

Keywords

Evoked Potentials3-(2,4-dimethoxybenzylidene)anabaseineDMXB-AReceptors, Nicotinic

Outcome Measures

Primary Outcomes (1)

  • Total Scale Score for the Repeatable Battery for the Assessment of Neuropsychological Status

    ten subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).

    Measured at 2 hours after drug or placebo

Secondary Outcomes (2)

  • Brief Psychiatric Rating Scale

    Measured 4 hours after drug or placebo administration

  • P50 auditory evoked potential test amplitude/conditioning amplitude ratio

    Measured 2.5 hours after drug or placebo administration

Study Arms (3)

Dimethoxybenzylidene anabaseine 75 mg

EXPERIMENTAL

Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 75 mg)

Drug: Dimethoxybenzylidene anabaseine (DMXB-A)Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will take placebo.

Drug: Dimethoxybenzylidene anabaseine (DMXB-A)Drug: Placebo

Dimethoxybenzylidene anabaseine 150 mg

EXPERIMENTAL

Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 150 mg)

Drug: Dimethoxybenzylidene anabaseine (DMXB-A)Drug: Placebo

Interventions

Dimethoxybenzylidene anabaseine (DMXB-A)DRUG

DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose

Dimethoxybenzylidene anabaseine 150 mgDimethoxybenzylidene anabaseine 75 mgPlacebo
PlaceboDRUG

Placebo dosed to match active medication

Dimethoxybenzylidene anabaseine 150 mgDimethoxybenzylidene anabaseine 75 mgPlacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia

You may not qualify if:

  • History of cardiovascular illness or neurological illness other than schizophrenia
  • Current substance abuse, including nicotine
  • History of clozapine use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado General Clinical Research Center

Denver, Colorado, 80262, United States

Location

Related Publications (1)

  • Martin LF, Kem WR, Freedman R. Alpha-7 nicotinic receptor agonists: potential new candidates for the treatment of schizophrenia. Psychopharmacology (Berl). 2004 Jun;174(1):54-64. doi: 10.1007/s00213-003-1750-1. Epub 2004 Feb 19.

    PMID: 15205879BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

3-(2,4-dimethoxybenzylidene)anabaseine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Robert Freedman, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

March 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

US(1)