CClinicalTrials.gg
Sign In
CompletedNCT00404573Updated Jan 7, 2008

Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia

A Phase 2 interventional study of RGH-188 in Schizophrenia, sponsored by Forest Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-01-07.

Sponsored by Forest Laboratories · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
375
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a study designed to evalute the safety and efficacy of RGH-188 in the treatment of acute schizophrenia. This study will be 10 weeks in duration; 6 weeks double-blind treatment, and 4 weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of the three treatment groups--one of two doses of RGH-188 or placebo

02

Conditions studied

  • Schizophrenia

Browse trials for

Keywords

  • Schizophrenia
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 375 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and female inpatients, 18-65 years of age, meeting DSM-IV-TR criteria for schizophrenia and having a Total Positive and Negative Syndrome Scale (PANSS) Score >=80 and \<=120. A score >=4 on item P1 (delusions) or P3 (hallucinatory behavior) and a score of >=4 on item P2 (conceptual disorganization) or P6 (suspiciousness/persecution) of the PNASS

Exclusion criteria

Exclusion Criteria:

  • Patients with documented disease of the central nervous system that can interfere with the trial assessments, including but not limited to stroke, tumor, Parkinson's, organic brain disease, seizure disorder (except for febrile convulsions during infancy), chronic infection, or neurosyphilis; or patients who have suffered a traumatic brain injury resulting in significant impairment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
375 participants (estimated)

Interventions

  • DrugRGH-188
06

What researchers measure

Primary outcomes

  1. PANSS Total Score

Secondary outcomes

  1. CGI-S

07

Study locations

1 site
  • For information regarding investigative sites, contact Forest Professional Affairs
    St Louis, Missouri 63045, United States
08

References and documents

Publications

  • Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6. PubMed 34091867 ↗
  • Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021. Erratum In: Neuropsychiatr Dis Treat. 2021 May 17;17:1481. doi: 10.2147/NDT.S316858. PubMed 33854317 ↗
  • Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187. PubMed 28692485 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00404573
Lead sponsor
Forest Laboratories
First posted
Nov 29, 2006
Start date
Nov 2006
Primary completion
Aug 2007
Last update
Jan 7, 2008
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. 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.

Other studies in this condition

Schizophrenia→

Other studies from this sponsor

Forest Laboratories

Start the discussion