Tetrabenazine for Partial Responders

NCT00362804 | Completed

• 1 other identifier: 240/2001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia; Schizoaffective Disorder

Keywords

tetrabenazine; partial response; psychosis; schizophrenia; schizoaffective disorder; partial response to antipsychotics

Outcome Measures

Primary Outcomes (2)

• BPRS

  weekly assessments

• CGI

  weekly assessment

Secondary Outcomes (5)

• GAF/NOISE

  weekly

• SAS

  weekly

• AIMS

  weekly

• BAS

  weeekly

• UKU (a general measure of adverse effects)

  weekly

Interventions

Tetrabenazine DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has been on an antipsychotic medication for at least 3 months and achieved the maximum dose vis à vis tolerability/side effects.
• Partial response to antipsychotic medication (CGI \> 4; BPRS \[Anchored, 18-item\] total \> 30; single item score \> 4 on 2 positive symptom items)
• has been on at least 2 previous antipsychotic trials of 4-6 weeks in duration at a dose reaching 400-600 mg chlorpromazine (or equivalent) with no clinical improvement

You may not qualify if:

• age \< 18 or \> 65
• previous documentation of hypersensitivity to tetrabenazine
• SCID criteria for a current depressive episode
• MAOI administration within 2 weeks of tetrabenazine treatment
• concomitant desipramine use
• diagnosis of idiopathic Parkinson's disease and/or levodopa treatment
• current unstable medical illness and current substance abuse

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Tetrabenazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quinolizines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gary Remington, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 10, 2006
• Study Start: February 1, 2002
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: July 6, 2012

Record last verified: 2012-07

Locations

CA (1)