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
- Diseases
- Schizophrenia
- 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
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| „Center for mental health – Prof. Ivan Temkov – Burgas” EOOD Coordinator of this site? Confirm its status | Burgas | Bulgaria | Completed |
| Medical Center Lifemed EOOD Coordinator of this site? Confirm its status | Kirdzhali | Bulgaria | Completed |
| Medical Center Medconsult Pleven OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Center For Mental Health Prof. N. Shipkovenski EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Multiprofile Hospital For Active Treatment - Targovishte AD Coordinator of this site? Confirm its status | Targovishte | Bulgaria | Completed |
| Diagnostics-Consultancy Center Mladost M Varna OOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Completed |
| A-Shine s.r.o. Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Completed |
| INEP medical s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Clintrial s.r.o. Coordinator of this site? Confirm its status | Prague 10 | Czechia | Completed |
| E4r&D Sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Specjalistyczna Praktyka Lekarska Piotr Zalitacz Coordinator of this site? Confirm its status | Gorlice | Poland | Completed |
| Centrum Zdrowia Psychicznego BIOMED - Jan Latała Coordinator of this site? Confirm its status | Kielce | Poland | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Centrum Medyczne Luxmed Sp.z. o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Praktyka Lekarska Małgorzata Wojtanowska-Bogacka Coordinator of this site? Confirm its status | Poznań | Poland | Completed |
| Recognify Research Site Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Berlin | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Culver City | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Everett | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| Collaborative Neuroscience Research Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Oceanside | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Recognify Research Site Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.