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NCT05686239CompletedPhase 2

A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)

An Adaptive, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)

Source: ClinicalTrials.gov · Last updated 30 Jul 2025

Brief summary (registry, in English)

The goal of this clinical trial is to evaluate if the investigational drug, RL-007, can improve the cognitive performance of subjects with schizophrenia. The main questions the study aims to answer are: 1. Does RL-007 improve subjects performance in a set of cognitive tasks? 2. Which dose of RL-007 (20 mg or 40 mg) has a larger effect on cognitive performance? 3. How well do subjects tolerate RL-007? In the study, subjects will perform the cognitive tasks at the beginning to get familiar with the tasks. Then, subjects will be given either RL-007 or a placebo for 6 weeks and then repeat the cognitive tasks. The researchers will compare the results at the end of the treatment period to the baseline to see if there have been any changes in performance. Additionally, several safety measures will be collected throughout the study (blood pressure, physical exam, ECGs, etc) to evaluate if there are any side effects from taking RL-007.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
242 (actual)
First submitted
28 Dec 2022
Start date
8 Dec 2022
Primary completion date
9 Apr 2025
Lead sponsor
Recognify Life Sciences
NCT number
NCT05686239
EU CT number
2023-506570-12-01

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 242
  • From 8 Dec 2022 to the primary completion date, 9 Apr 2025
  • 36 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of hospitalization for medical indication or psychiatric hospitalization within 3 months prior to screening.
  • Meets criteria for moderate to severe substance/drug abuse disorder (including alcohol) per DSM-5 within the last 6 months prior to informed consent or a positive alcohol breath test or urine test for drugs of abuse at either Screening or Randomization Visits (except for benzodiazepines taken according to prescription and as an ongoing, stable regimen).
  • Participant has undergone electroconvulsive therapy within the past 12 months.

Other illness

  • Current diagnosis of another major psychiatric disorder, intellectual disability, or any major neurological disease, brain injury, epilepsy, or severe brain trauma.
  • Evidence or history of significant cognitive impairment, other than associated with schizophrenia, that in the judgement of the Investigator or Sponsor would confound interpretation of study data or prevent safe and satisfactory completion of the study protocol.

Other

  • Participants who present a serious risk of suicide, as evidenced by a) "yes" on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) and meeting these criteria within the past 6 months, or b) posing a significant suicide risk in the Investigator's judgement.
  • Participants who present a risk of serious harm to others, as evidence by any history within the past 2 years and any expressed homicidal ideation (with or without plan).

Who the study is looking for

  • Diagnosis of schizophrenia, per Diagnostic and Statistical Manual (DSM) 5, with a duration of at least 6 months
  • Positive and Negative Symptoms Severity Score (PANSS) of less than or equal to 80 (inclusive)
  • Currently treated on a single atypical antipsychotic (other than clozapine) at a stable dose and clinically stable for at least 6 weeks before randomization
  • Clinical Global Impression - Severity score \< 5.
  • Body mass index (BMI) \<= 40.0 kg/m\^2 at screening
  • Participant has reliable housing that is not expected to change during the study period with no expected significant life events that could affect study outcomes throughout entire study period.
  • Sufficient fluency in English to understand and complete study instructions and assessments

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
„Center for mental health – Prof. Ivan Temkov – Burgas” EOOD
Coordinator of this site? Confirm its status
BurgasBulgariaCompleted
Medical Center Lifemed EOOD
Coordinator of this site? Confirm its status
KirdzhaliBulgariaCompleted
Medical Center Medconsult Pleven OOD
Coordinator of this site? Confirm its status
PlevenBulgariaCompleted
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Coordinator of this site? Confirm its status
PlovdivBulgariaCompleted
Center For Mental Health Prof. N. Shipkovenski EOOD
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
Multiprofile Hospital For Active Treatment - Targovishte AD
Coordinator of this site? Confirm its status
TargovishteBulgariaCompleted
Diagnostics-Consultancy Center Mladost M Varna OOD
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VarnaBulgariaCompleted
A-Shine s.r.o.
Coordinator of this site? Confirm its status
Plzen 3CzechiaCompleted
INEP medical s.r.o.
Coordinator of this site? Confirm its status
PragueCzechiaCompleted
Clintrial s.r.o.
Coordinator of this site? Confirm its status
Prague 10CzechiaCompleted
E4r&D Sp. z o.o.
Coordinator of this site? Confirm its status
GdanskPolandCompleted
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
Coordinator of this site? Confirm its status
GorlicePolandCompleted
Centrum Zdrowia Psychicznego BIOMED - Jan Latała
Coordinator of this site? Confirm its status
KielcePolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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LodzPolandCompleted
Centrum Medyczne Luxmed Sp.z. o.o.
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LublinPolandCompleted
Praktyka Lekarska Małgorzata Wojtanowska-Bogacka
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PoznańPolandCompleted
Recognify Research Site
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AtlantaUnited StatesUnknown status
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AugustaUnited StatesUnknown status
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BerlinUnited StatesUnknown status
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BrooklynUnited StatesUnknown status
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Chapel HillUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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Culver CityUnited StatesUnknown status
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DallasUnited StatesUnknown status
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EverettUnited StatesUnknown status
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GaithersburgUnited StatesUnknown status
Collaborative Neuroscience Research
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Garden GroveUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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LafayetteUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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Miami LakesUnited StatesUnknown status
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OceansideUnited StatesUnknown status
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OrangeUnited StatesUnknown status
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TorranceUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.