TAAR1 partial agonist in patients With negAtive symptoms of schIzophreNia or schIzoaffective disorder
This clinical research study will test the effectiveness of an investigational medication related to schizophrenia or schizoaffective disorder with negative symptoms.
You, a friend, or a family member maybe eligible to participate if they are 18-55 years old and have been diagnosed with schizophrenia or schizoaffective disorder. Participants must also have negative symptoms associated with their schizophrenia. To qualify, someone with negative symptoms may lack in facial expressions, speech, social interests, and motivation.
Schizophrenia has no cure and limited long-term effective medication available on the market for prescribing physicians. Referring your patient to a clinical trial increases the chances of combating this disease along with potentially helping reduce the symptoms of schizophrenia for your patient.
Physicians that conduct clinical research studies try to involve the patient’s treating doctor during the trial participation as much as permitted. The extent of communication throughout the trial is solely based off what is permitted to be shared on the participants medical release authorization form.
The patient can choose to not allow the trial doctor to communicate with you and the patient may also decide to not continue being seen by you. Participants are highly encouraged to continue their normal routine follow up visits with their doctors throughout the trial.
Physicians are seeking volunteers 18 to 55 years old to participate in a clinical study for the care and treatment of schizophrenia or schizoaffective disorder with negative symptoms.
Qualified participants can expect to stay in the study for approximately 5 months. During this time frame, individuals may participate in study activities and tests.
This is a randomized, double-blind, placebo-controlled study. Which means some participants may receive the investigational medication, and others will receive a placebo in addition to the background treatment with a standard antipsychotic.
A placebo looks exactly like the investigational medication but has no active ingredients.
Information from this study may help the medical community learn more about potential treatment options for schizophrenia and could help other individuals, even if it may not help you. Additionally, all study-related care is no-cost to the participant.
Schizophrenia affects about 1% of adults worldwide. The exact cause of schizophrenia is unknown, but typically signs begin in late adolescence and early adulthood. There are three types of symptoms: cognitive, positive, and negative symptoms. These core symptoms contribute to difficulties in work, social relationships, and independent living.
Some people who suffer from schizophrenia may have cognitive symptoms like, trouble paying attention, poor memory, difficulty with problem solving and slowed thinking. Positive symptoms include hearing voices (hallucinations) and an unshakable belief in something that is not true (delusions). Many people with schizophrenia also experience “negative symptoms,” such as disinterest in social interaction, loss of motivation, and apathy (lack of caring).
People with schizophrenia can take medication to help manage their symptoms, but there is currently no cure for this disease.
Carefully conducted clinical trials are performed in human volunteers to provide answers to questions such as: does a treatment work, and does it have side effects. All approved medications, even over-the- counter cold and pain medications, have been tested in clinical research studies. All clinical research studies are overseen by institutional review boards.
“Investigational” means this medication is still being tested and has not been approved yet by any national health authority, including the US Food and Drug Administration (FDA).
There will be no charge for the study medication or placebo while participating in this study. Also, all procedures that are required only for this study and are not part of the regular standard of care, will be provided at no charge. Participation in the study may include compensation for your time and travel.
Normally, transportation would be organized by you or your study partner/caregiver. Someone with the trial team may be available to help arrange transportation or reimbursement for transportation for participants. Be sure to discuss travel needs during your first phone call with us.
The participant may or may not benefit as a result of their participation in this study. The participant also may or may not respond to treatment with the study medication. The information collected from this study may help doctors learn more about RO6889450 and the treatment of schizophrenia/schizoaffective disorder. This information may benefit other patients with schizophrenia/schizoaffective disorder or a similar condition in the future.
The research team is not authorized to tell anyone about participants in a research study without permission, except as required by law. All the information collected during the study will be kept confidential, and personal identifiers won‘t be listed in any reports based on the study.
Yes, taking part in a research study is the participant’s choice. Participants have the right to leave a research study at any time. If your family member or friend wants to withdraw from the study, he/she should tell the doctor or research team. Leaving the study will not affect their medical care.
If you, or someone you know are interested in participating in the TWAIN I Study complete the form to speak with a study representative regarding eligibility and available study locations.