Depression Trial 3

MAC understand that not all patients respond sufficiently well to current antidepressants and there is a need for more effective treatments for those with depression and anxiety.

The purpose of this trial is to see if the study drug is safe and effective for treating patients with Major Depressive Disorder (MDD) with anxious distress who have not had an adequate response to their current antidepressant medication.

Addressing anxiety symptoms in the context of depression may lead to improved outcomes for patients and more rapid relief of depression symptoms.

The study will last approx. 12 weeks and over that time there’ll be 7 visits.

The study has a 1:1 ratio with placebo (dummy drug) and you will take the study medication for six weeks. You will stay on your current anti-depressant therapy throughout the trial.

A full description of the study will be given before you decide to take part, both over the phone and during an appointment at a MAC clinic. This will include you receiving the full patient information sheet (PIS).

Criteria:

Key Inclusion Criteria*

• Males and females aged 18 – 64.
• Diagnosis of depression with anxious distress.
• Currently taking a stable dosage of eligible SSRI/SNRI.
• BMI 18 – 36 kg/m2

Key Exclusion Criteria*

• Prescribed Fluvoxamine
• A diagnosis of any major psychiatric condition including the following; delusions or hallucinations present along with depression, bipolar disorder, borderline personality disorder Schizophrenia, eating disorder, obsessive-compulsive disorder
• History of MS, optic neuritis or any demyelinating disease

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Other eligibility criteria will apply. Please contact MAC for more information.

Any other information

Eligible patients will receive a health screen and study participation will be in collaboration with the patient’s treating physician.