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Tetrabenazine for Partial Responders

NCT00362804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2012-07-06

No results posted yet for this study

Summary

Purpose of Study:

A) To improve outcome in large population of antipsychotic patients with schizophrenia or schizoaffective who are only partial responders B) To increase understanding of pharmacology and mechanisms of action underlying antipsychotic effect

Hypothesis/Objectives of the Study:

Tetrabenazine, through its pre-synaptic action, should augment the post-synaptic effects of an antipsychotic.

Background and Rationale for the study:

Preliminary evidence that other amine-depleting agents e.g., reserpine, can induce such an effect

Conditions

Interventions

DRUG

Tetrabenazine

The initial TBZ dose will be 12.5 mg and the dose will be increased to 25 mg at Week 2. Thereafter, the dose can be decreased to 12.5 mg or increased in 12.5 mg increments at weekly intervals, depending on clinical response and tolerability, to a maximum of 75 mg/day. For 37.5 and 50 mg daily, administration will be BID i.e., 25 mg QAM, 12.5 or 25 mg QHS. For 62.5 or 75 mg daily, a TID dosing will be employed i.e., 25 mg QAM, 12.5 or 25 mg QPM, 25 mg QHS

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Gary Remington, MD · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2006-01-31
Completion
2006-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00362804 on ClinicalTrials.gov