Objective of the trial is to study if famotidine add-on treatment is more effective than placebo add-on in reducing symptoms of schizophrenia among patients receiving insufficient response to ongoing antipsychotic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
100mg x 2 p.o.
Helsinki University Central Hospital Psychiatry Centre
Helsinki, Finland
RECRUITINGHelsinki University
Helsinki, Finland
ACTIVE_NOT_RECRUITINGSocial services and Healthcare, City of Helsinki
Helsinki, Finland
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at 8 weeks
In addition PANSS ratings are done at screening, every two weeks during treatment and two weeks after end of treatment.
Time frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)
Change from Baseline in Clinical Global Impression (CGI) scale at 8 weeks
In addition CGI ratings are done at screening, every two weeks during treatment and two weeks after end of treatment.
Time frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)
Change from Baseline in Calgary Depression Scale (CDS) at 8 weeks
Time frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)
Change from Baseline in The Overall Anxiety Severity and Impairment Scale (OASIS)at 8 weeks
Time frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)
Change from Baseline in CogState scores at 8 weeks
A standardized, language independent computerized battery of cognitive tests (CogState®). This battery has been validated and shown to be a sensitive indicator of mild impairments in the following cognitive domains: psychomotor speed, attention, working memory and episodic learning and memory.
Time frame: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)
Change from baseline in nightly sleep duration measured with actigraphy at 8 weeks
Average nightly sleep duration of seven nights before and after intervention measured with an actigraph
Time frame: Measurement at start of treatment (0 weeks) and at end of treatment (8 weeks)
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Kellokoski Hospital
Hyvinkää, Finland
RECRUITINGKarolinska Institutet
Stockholm, Sweden
RECRUITINGNorra Stockholms Psykiatri, Stockholm County Council
Stockholm, Sweden
RECRUITING