ClinicalTrials.gg
Sign In
Status unknownNCT00395915CHATUpdated Feb 18, 2009

Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia

A Phase 4 interventional study of aripiprazole in Schizophrenia, sponsored by Universita di Verona. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-18.

Sponsored by Universita di Verona · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The principal clinical question to be answered by CHAT (Clozapine Haloperidol Aripiprazole Trial) is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared to combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time.

02

Conditions studied

  • Schizophrenia

Browse trials for

Keywords

  • schizophrenia
  • antipsychotics
  • treatment non response
  • pragmatic trial
03

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's enrollment of 106 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Universita di Verona is the lead sponsor of 125 studies on the registry; 27 are open to participants now.

Browse Universita di Verona studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. Current treatment with clozapine for the primary indication of schizophrenia (clinical diagnosis, guided by DSM-IV criteria).
  2. Treatment with clozapine for at least six months at a stable dose of 400 mg or more per day, unless the size of the dose was limited by side-effects.
  3. Unsatisfactory benefit from clozapine treatment, as indicated by the presence of positive symptoms (delusions, hallucinations, abnormal behaviour, clinical diagnosis)
  4. Age 18 and above.
  5. Agreement between investigator and patient to enter the study.
  6. The patient is normally resident in Italy.
  7. It is considered clinically reasonable to try combination treatment with clozapine and aripiprazole or with clozapine and haloperidol.
  8. Uncertainty about which trial treatment would be best for the participant.
  9. No medical disorder or condition contraindicates either of the investigational drugs.
  10. Agreement between investigator and patient to discontinue any antipsychotic drugs other than clozapine (including long-acting antipsychotic drugs).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Withdrawal from allocated treatment within 3 months.

Secondary outcomes

  1. Withdrawal from allocated treatment within 12 months of follow-up.

  2. Time to withdrawal from allocated treatment.

  3. Severity of illness, measured at month 3 and 12.

  4. Withdrawal from study treatment, due to adverse reactions, within 3 and 12 months.

  5. Concurrent use of adjunctive medication within 3 and 12 months.

  6. Concurrent use of antiparkinson medication within 3 and 12 months.

  7. Adverse events within 3 and 12 months.

  8. Biological parameters, measured at month 3 and 12.

  9. Metabolic syndrome within 3 and 12 months.

  10. Subjective tolerability of antipsychotic drugs, measured at month 3 and 12.

  11. Deliberate self-harm within 3 and 12 months.

07

Study locations

1 site
  • University of Verona
    Verona, 37124, Italy
08

References and documents

Publications

  • Cipriani A, Accordini S, Nose M, Purgato M, Girlanda F, Tansella M, Barbui C. Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia: a 12-month, randomized, naturalistic trial. J Clin Psychopharmacol. 2013 Aug;33(4):533-7. doi: 10.1097/JCP.0b013e318296884f. PubMed 23775051 ↗
  • Barbui C, Accordini S, Nose M, Stroup S, Purgato M, Girlanda F, Esposito E, Veronese A, Tansella M, Cipriani A; CHAT (Clozapine Haloperidol Aripiprazole Trial) Study Group. Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia in routine clinical care: a randomized, controlled trial. J Clin Psychopharmacol. 2011 Jun;31(3):266-73. doi: 10.1097/JCP.0b013e318219cba3. PubMed 21508849 ↗
  • Nose M, Accordini S, Artioli P, Barale F, Barbui C, Beneduce R, Berardi D, Bertolazzi G, Biancosino B, Bisogno A, Bivi R, Bogetto F, Boso M, Bozzani A, Bucolo P, Casale M, Cascone L, Ciammella L, Cicolini A, Cipresso G, Cipriani A, Colombo P, Dal Santo B, De Francesco M, Di Lorenzo G, Di Munzio W, Ducci G, Erlicher A, Esposito E, Ferrannini L, Ferrato F, Ferro A, Fragomeno N, Parise VF, Frova M, Gardellin F, Garzotto N, Giambartolomei A, Giupponi G, Grassi L, Grazian N, Grecu L, Guerrini G, Laddomada F, Lazzarin E, Lintas C, Malchiodi F, Malvini L, Marchiaro L, Marsilio A, Mauri MC, Mautone A, Menchetti M, Migliorini G, Mollica M, Moretti D, Mule S, Nicholau S, Nose F, Occhionero G, Pacilli AM, Pecchioli S, Percudani M, Piantato E, Piazza C, Pontarollo F, Pycha R, Quartesan R, Rillosi L, Risso F, Rizzo R, Rocca P, Roma S, Rossattini M, Rossi G, Rossi G, Sala A, Santilli C, Sarao G, Sarnicola A, Sartore F, Scarone S, Sciarma T, Siracusano A, Strizzolo S, Tansella M, Targa G, Tasser A, Tomasi R, Travaglini R, Veronese A, Ziero S. Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia. Trials. 2009 May 15;10:31. doi: 10.1186/1745-6215-10-31. PubMed 19445659 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2006, a primary completion of Mar 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2006
First posted
Nov 6, 2006
Start
Sep 2006
Primary completionEst.
Mar 2009
CompletionEst.
Dec 2009
Last update
Feb 18, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00395915
Lead sponsor
Universita di Verona
First posted
Nov 6, 2006
Start date
Sep 2006
Primary completion
Mar 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
Feb 18, 2009

Study contacts

Michele Tansella, MD
study chair · Universita di Verona

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Aripiprazole

Other studies in this condition

Schizophrenia →

Other studies from this sponsor

Universita di Verona →

Start the discussion