Amisulpride Augmentation in Clozapine-unresponsive Schizophrenia
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
Schizophrenia is a mental health problem usually starting in the late teens/early twenties,
and often lasting many years. The standard medication ('antipsychotics') for this problem is
usually helpful, and if taken continually can keep people well, reducing the likelihood of
further episodes. However, in up to one in three people with schizophrenia, the illness does
not show much improvement with antipsychotic medication. For some of these 'resistant'
illnesses, one particular antipsychotic, clozapine, can work well, but one disadvantage is
the risk of a severe blood side effect which means that regular blood testing is necessary.
If the response to clozapine treatment is disappointing, there is some evidence that adding
another antipsychotic can sometimes produce more improvement. However, it seems that the
added antipsychotic may need to be taken by the person for at least 10 weeks in order to work
well. The investigators plan to test carefully the possible benefits and problems when the
antipsychotic amisulpride or a dummy tablet ('placebo') is added to clozapine for 12 weeks in
people whose schizophrenia illness has not been helped much by any antipsychotic medication
on its own, and who are now taking clozapine, but again with not much improvement. The
investigators have chosen amisulpride because its pharmacological action may be complementary
to that of clozapine, and also it is less likely than some other antipsychotics to compound
some of the characteristic side effects of clozapine, such as sedation, weight gain and other
metabolic problems.
Adjunctive amisulpride or placebo will be randomly assigned. The investigators expect that
adding amisulpride will be more likely to cause an improvement than adding placebo. But the
investigators should learn more about the risks and side effects of combining these two
medications. Also, the investigators should gain a greater understanding of the possible
benefits of adding another antipsychotic to clozapine in relation to particular problem
symptoms, and a person's ability to live and work in the community.
Phase:
Phase 4
Details
Lead Sponsor:
Imperial College London
Collaborators:
University College, London University of Manchester