A 14-week, multicentre, double-blind, randomised, placebo-controlled phase II study with an 8-week treatment period to assess the efficacy and tolerability of a fixed dose of BH-200 (250 mg BID) in outpatients with Major Depressive Disorder (MDD) - OLIVE

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 21.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2022-002757-26-DE
• Lead Sponsor: HMNC Holding GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-28
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

1. Male or female patients.
2. Between 18 and 75 years of age at the date of informed consent.
3. Body mass index between 18 and 35 kg/m2.
4. Outpatients.
5. Ability of the participant to understand the purpose and risks of the study and provide signed and dated initial informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
6. Provide written informed consent.
7. Primary diagnosis of MDD, moderate or severe, single or recurrent episode, with or without psychotic features as defined by Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI). However, patients with the following co-morbid conditions can be included (secondary diagnosis):
a) Patients with anxiety disorders as long as the primary diagnosis is MDD.
b) Patients with obsessive-compulsive disorder as long as the primary diagnosis is MDD and the current condition is not impairing/disabling or interfering with the patient’s adherence to study drug and protocol.
c) Patients with eating disorders as long as the primary diagnosis is MDD and the condition does not impact the efficacy of the study drug or raise safety concerns in the investigator’s opinion.
8. MADRS score =20 at screening and baseline.
9. Duration of current episode no longer than 12 months, prior to screening.
10. Symptoms of depression present for at least 2 weeks, prior to screening.
11. Willingness to stop current antidepressive medication or other prohibited psychotropic medication, at least 7 days or 5 half-lives, whichever is longer, before baseline (day 0).
12. Psychotherapy that has been ongoing for a minimum of 6 weeks prior to screening can continue, but new psychotherapy may not be initiated from 6 weeks prior to screening until 8 weeks after start of treatment.
13. Physical activity programmes that have been ongoing for a minimum of 6 weeks prior to screening can continue but should be kept on the same level (i.e., type and frequency), but new physical activity programmes may not be initiated from 6 weeks prior to screening until 8 weeks after start of treatment.
14. Ongoing hormone substitution therapy for post-menopausal women, insulin treatment for diabetes and thyroid disorders is allowed as long as these conditions are well controlled
15. Women of childbearing potential will be required to use highly effective contraceptive measures from the time of informed consent until 28 days after last intake of the investigational drug.
16. Male patients will be required to use highly effective contraceptive measures (barrier method) or practice abstinence during this study and for 28 days after last intake of investigational drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 259
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. Inability to obtain written informed consent from the patient or to comply with the protocol and follow written and verbal instructions.
2. Pregnant, lactating females.
3. Patients with schizophrenia spectrum and other psychotic disorders and bipolar disorders.
4. Patients with paranoid, schizoid, and schizotypal personality disorder.
5. Patients with antisocial, borderline (emotionally unstable personality disorder, borderline type), histrionic and narcissistic personality disorder.
6. Patients with intellectual disability / mental retardation, e.g., due to neurodevelopmental disorders, neurocognitive or neurodegenerative disorders, and autism spectrum disorder.
7. Patients with PTSD.
8. Significant risk of suicide.
9. Patients with known or suspected lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder, epilepsy, or any other disease/procedure/accident/intervention which, according to the screening clinician, is deemed associated with significant injury to or malfunction of the CNS, or history of significant head trauma within the past 2 years prior to screening, with the exception of uncomplicated childhood febrile seizures with no sequelae.
10. Patients with known or suspected cardiovascular or cerebrovascular disease (e.g., unstable angina, congestive heart failure, tachyarrhythmia, myocardial infarction, stroke, prolonged ischaemic neurologic deficit and transient ischaemic attack), as well as patients who have:
-Abnormal ECG at screening
-Heart rate <50 or >110 beats per minute at screening or baseline.
-History of sudden cardiac death in a first degree relative.
-Patients with untreated hypertension and a systolic blood pressure (BP) at rest >160 mmHg and/or diastolic BP at rest >100 mmHg.
11. Patients with a history of, or symptoms and signs suggestive of, impaired hepatic function or cirrhosis.
12. Patients with a history of Hepatitis B or C.
13. Patients with Cushing’s Syndrome.
14. Patients with Addison’s Disease.
15. Renal insufficiency.
16. Patients with uncontrolled diabetes (glycated haemoglobin [HbA1c] >8.0% at screening).
17. Patients with known but untreated conditions causing hyperthyroidism or hypothyroidism with the following exceptions:
-Patients with a pre-existing history of hypothyroidism who are treated with thyroid hormones must be on a stable dosage for 6 weeks before baseline, are allowed into the study.
-Patient must have thyroid stimulating hormone (TSH) and free thyroxine (fT4) within normal range at screening. If there is a low TSH or high fT4 in a patient on levothyroxine, the patient could be re-screened after re-adjustment of levothyroxine dose and in-range levels of TSH and fT4 are attained.
-Patients on thyroid suppressant medication.
18. Patients with any significant disease or disorder (e.g., cardiovascular, haematological, pulmonary/respiratory, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.
19. Patients with a history of moderate to severe alcohol use and/or substance use disorder.
20. Prior intermittent use of cannabinoids prior to screening is not exclusionary if the p

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified