ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000954022

Ethics application status

Approved

Date submitted

2/11/2010

Date registered

8/11/2010

Date last updated

8/11/2010

Type of registration

Retrospectively registered

Titles & IDs

Public title

An open randomised clinical trial involving Haloperidol, Olanzapine, Quetiapine, Risperidone, and Ziprasidone in first episode never-treated psychosis

Scientific title

Antipsychotic discontinuation in first-episode never-treated psychosis: an open randomised clinical trial involving Haloperidol, Olanzapine, Quetiapine, Risperidone, and Ziprasidone

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Antipsychotic discontinuation in first episode psychosis

Condition category

Condition code

Mental Health

Schizophrenia

Mental Health

Psychosis and personality disorders

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients were randomized to open-label antipsychotic treatment with the following dose ranges: olanzapine 7.5-40 mg/day, risperidone 1.5-7.0 mg/day, quetiapine 100–1500 mg/day, and ziprasidone 40–240 mg/day. Study medication was administered orally with the doses prescribed at the treating psychiatrist's discretion. Participants randomized to each second generation antipsychotic received the assigned antipsychotic for 12 months on a daily basis.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Haloperidol arm: orally administration for 12 months on a daily basis. Doses ranged from 1.5-8.5 mg/day at the treating psychiatrist's discretion.

Control group

Active

Outcomes

Primary outcome [1]

Retention of patients on treatment was considered a measure for effectiveness (primary outcome measure) and defined as the time to discontinuation from the antipsychotic to which patients were originally randomized.

Timepoint [1]

Baseline (antipsychotic-naive), 6 weeks, 3 months, 9 months and 12 months.

Secondary outcome [1]

Symptom change at each timepoint as measured by the Positive and Negative Syndrome Scale (PANSS)

Timepoint [1]

Baseline (antipsychotic-naive), 6 weeks, 3 months, 9 months and 12 months.

Secondary outcome [2]

Symptom change at each timepoint as measured by the Calgary Depression Symptom Scale (CDSS)

Timepoint [2]

Baseline (antipsychotic-naive), 6 weeks, 3 months, 9 months and 12 months

Secondary outcome [3]

Premorbid Adjustment using the PAS

Timepoint [3]

Baseline

Eligibility

Key inclusion criteria

Showing psychotic symptoms at admission (having a score of 4 or more on PANSS positive scale items 1, 3, 5, or 6) and being naive of antipsychotic, antidepressant or mood stabilizer treatment.

Signing a consent document

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Presence of a major medical or neurological disease, mental retardation, suspicion of substance use directly contributing to the emergence of symptoms (not merely a comorbid condition) and previous treatment with psychotropic drugs.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients were recruited from psychiatric emergency units from 3 hospitals located in the metropolitan area of Barcelona, Spain.
Eligible subjects met inclusion criteria and did not meet exclusion criteria.
Allocation was performed by the psychiatrist's in charge of the patient's inclusion and consisted in contacting by phone the holder of the allocation procedure at a central administration site. Patients were immediately randomized to antipsychotic treatment to haloperidol, olanzapine, risperidone, quetiapine, or ziprasidone.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer generated randomization followed a 1:1:1:1:1 procedure into the 5 treatment groups.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2002

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Barcelona

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Fundacio La Marato TV3

Address [1]

Ganduxer 117, 08022 Barcelona

Country [1]

Spain

Primary sponsor type

Commercial sector/Industry

Name

Lilly

Address

Avda de la Industria 30, 28108 Alcobendas, Madrid

Country

Spain

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comite de Etica de Investigacion Clinica. Hospital San Rafael

Ethics committee address [1]

Passeig Vall Hebron 107-117, 08028 Barcelona

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

Approval date [1]

01/11/2001

Ethics approval number [1]

Summary

Brief summary

The goal of this study was to perform a pragmatic, open, randomized clinical trial comparing the 12-month effectiveness (measured by time to discontinuation) of several second-generation antipsychotic drugs, with that of low doses of haloperidol in never-treated FEP.
Method: 150 patients were randomized to open-label antipsychotic treatment with haloperidol, olanzapine, risperidone, quetiapine, and ziprasidone. Retention of patients on treatment was considered a measure for effectiveness (primary outcome measure). Secondary outcomes included symptom change by antipsychotic as measured by the Positive and Negative Syndrome Scale (PANSS).

Trial website

none

Trial related presentations / publications

Ramirez N, Arranz B, Salavert J, Alvarez E, Corripio I, Duenas RM, Perez V, San L
Predictors of schizophrenia in patients with a first episode psychosis
Psychiatry Res 175: 11-14 (2010)


Arranz B, San L, Ramirez N, Duenas RM, Perez V, Salavert J, Corripio I, Alvarez E 
Clinical and serotonergic predictors of nonaffective acute remitting psychosis in patients with a first-episode psychosis
Acta Psychiatr Scand 119 : 71-77 (2009)


Arranz B, Rosel P, San L, Ramirez N, Duenas RM, Salavert J, Centeno M, del Moral E. 
Low baseline 5-HT2A receptors predict clinical response to olanzapine in first-episode schizophrenia patients
Psychiatry Res 153 : 103-109 (2007)


Arranz B, San L, Duenas RM, Centeno M, Ramirez N, Salavert J, del Moral E 
Lower weight gain with the orally disintegrating olanzapine than with standard tablets in first-episode never treated psychotic patients
Hum Psychopharmacol Clin Exp 22 :11-15 (2007)


Reynolds GP, Arranz B, Templeman L, Fertuzinhos S, San L
Negative and depressive symptom response to antipsychotic treatment of drug-naive psychotic patients is predicted by a 5-HT1A receptor gene polymorphism
Am J Psychiatry 163: 1826-1829 (2006)


Templeman LA, Reynolds GP, Arranz B, San L
Polymorphisms of the 5-HT2C receptor and leptin genes are associated with antipsychotic drug-induced weight gain in Caucasian subjects with a first-episode psychosis
Pharmacogenet Genomics 15(4): 195-200 (2005)


Arranz B, Rosel P, Ramirez N, Duenas MR, Fernandez P, Sanchez JM, Navarro M.A., San L
Insulin resistance and increased leptin concentrations in antipsychotic-free and not in naive first-episode schizophrenic patients
J Clin Psychiatry 65 :1335-1342 (2004)

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Luis San, MD, PhD

Address

Passeig Sant Joan de Deu, 2
ES 08950 Esplugues de Llobregat, Barcelona

Country

Spain

Phone

+34 629736820

Fax

12636LSM@COMB.CAT

Contact person for scientific queries

Name

Luis San, MD, PhD

Address

Passeig Sant Joan de Deu, 2
ES 08950 Esplugues de Llobregat, Barcelona

Country

Spain

Phone

+34 629736820

Fax

12636LSM@COMB.CAT

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Substance use in patients with first-episode psychosis: Is gender relevant?.	2015	https://dx.doi.org/10.1080/15504263.2015.1113761

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically