A Phase 2 interventional study of Talnetant and placebo in Schizophrenia, sponsored by GlaxoSmithKline. Completed at 22 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-29.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks and will then return for a follow-up visit 2 weeks later. About 275 patients with schizophrenia will be enrolled in this study.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 282 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
200mg, 400mg, 600mg) twice a day
Drug: Talnetant
placebo
Other: placebo
3mg twice a day
Other: risperidone
talnetant
Placebo Comparator
Active Comparator
The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
Time frame: 6 weeks
The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
Time frame: 6 weeks
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
GlaxoSmithKline