Phase 2 Depression and Anxiety Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to understand the trial and are willing to take part voluntarily, and who can sign a written consent form
• People aged 18 years or older
• People who have been diagnosed with Generalized Anxiety Disorder (GAD) according to a recognised set of medical guidelines (DSM-5), confirmed by a structured interview tool used by clinicians
• People whose anxiety symptoms require treatment with medication
• People who score at a certain level of anxiety severity (HAMA score of 20 or higher), show minimal signs of depression (HAMD-17 score of 2 or lower), and whose overall illness is rated as at least moderately severe (CGI-S score of 4 or higher) at both the screening and baseline assessments

Who may not be able to join:

• People who are currently considered to be at serious risk of suicide, or who score 3 or higher on the suicide-related question of a standard depression rating scale
• People whose depression score on a standard scale (HAMD-17) is higher than 17
• People whose anxiety scores dropped by 20% or more between the screening visit and the baseline visit
• People who meet the criteria for any other mental health condition besides GAD
• People with a previous history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorders, factitious disorder, or somatoform disorder; or people with a severe personality disorder (particularly antisocial, borderline, or histrionic type) that the trial doctors believe would affect their ability to follow the study procedures
• People who have misused or been dependent on alcohol or drugs in the 180 days before screening
• People with a serious or unstable physical health condition affecting the heart, kidneys, lungs, hormonal system (including thyroid problems), digestive system, blood (such as a tendency to bleed), nervous system, or who have cancer
• People whose anxiety disorder has not responded well to at least two previous anxiety or antidepressant medications taken at appropriate doses for at least 4 weeks each, or who did not benefit meaningfully from pregabalin at a dose of 300 mg per day or more
• People with a history of severe allergic reactions (such as anaphylaxis) to at least two types of medication, or who are known to be allergic to pregabalin, the trial drug, related compounds, or any of their ingredients
• People whose physical examination or blood pressure readings are abnormally high and considered clinically significant (for example, systolic blood pressure of 160 mmHg or higher, and/or diastolic blood pressure of 100 mmHg or higher)
• People with a history of epilepsy or any condition that may cause seizures, except for childhood febrile convulsions
• People with severely abnormal blood test results during screening, including low white blood cell, platelet, or red blood cell counts; abnormal liver function tests; reduced kidney function (eGFR below 60 mL/min/1.73m²); or elevated muscle enzyme levels (confirm with trial site for specific values)
• People with a significantly abnormal heart tracing (ECG), specifically a prolonged QT interval (450 ms or more for men, 470 ms or more for women), or other heart-related concerns identified by the trial doctors
• People who have had brain surgery, electroconvulsive therapy (ECT), or transcranial magnetic stimulation within the 90 days before screening
• People who have been taking beta-blocker medications within the 90 days before screening and still need to continue taking them
• People currently receiving talking therapies or other non-medication treatments such as acupuncture, hypnosis, or light therapy within 6 weeks before the baseline visit
• People who have difficulty swallowing or cannot take oral (swallowed) medication
• People with active digestive system conditions or a history of gastrointestinal surgery that the trial doctors believe could affect how the trial medication is absorbed
• People who have recently taken certain short-acting anti-anxiety medications (such as lorazepam, oxazepam, or alprazolam) within a specific time window before screening, or who have recently taken longer-acting versions (such as diazepam or clonazepam) within 30 days of screening, or who have taken barbiturate medications within 30 days of screening (confirm with trial site for exact timing requirements)
• People who stopped taking traditional Chinese medicine, melatonin, or St. John's Wort less than 3 days before the baseline visit
• People who are pregnant, planning to become pregnant, or breastfeeding during the study; or people who are unwilling to use reliable contraception from the time of signing consent until 28 days after the last dose of the trial medication; or people planning to use progesterone-based contraception during this period
• People whose work involves potentially dangerous activities such as working at heights or operating motor vehicles
• People who have taken part in another clinical trial within 30 days before screening
• People who the trial doctors consider unsuitable for the trial for any other reason

Important: Always verify eligibility with the trial site directly before applying.