Cariprazine in treatment of patients with Major Depressive Disorder

• Research type

  Research Study

• Full title

  A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CARIPRAZINE AS AN ADJUNCT TO ANTIDEPRESSANTS IN THE TREATMENT OF PATIENTS WITH MAJOR DEPRESSIVE DISORDER WHO HAVE HAD AN INADEQUATE RESPONSE TO ANTIDEPRESSANTS ALONE

• IRAS ID

  269172

• Contact name

  Ward Lawrence

• Contact email

  Ward.Lawrence@sabp.nhs.uk

• Sponsor organisation

  Allergan Ltd.

• Eudract number

  2018-002782-19

• Clinicaltrials.gov Identifier

  NCT03738215

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 10 months, 8 days

• Research summary

  Major depressive disorder (MDD) is a highly disabling, serious condition that is associated with significant morbidity and mortality. Worldwide, about 15% of the adult population is at lifetime risk of developing MDD.

  The purpose of this study is to look into the safety and efficacy of cariprazine as an add-on medication in the treatment of MDD. Cariprazine is not approved by the European Medicines Agency (EMA) for treatment of MDD.

  This research study is looking to enrol approximately 750 participants (male and female patients aged between 18 and 65 years old) with MDD.

  The patients will be assigned by chance to one of the following study groups:
  • Cariprazine 1.5 mg/day + current antidepressant treatment
  • Cariprazine 3mg/day + current antidepressant treatment
  • Placebo + current antidepressant treatment

  Since this is a double blind study, neither the patient nor the study doctor or study staff will know whether the patient is taking Cariprazine or placebo during the study. However, this information is available should the study doctor decide it is medically necessary. The investigational product will be administered orally once daily for 6 weeks.

  The study will consist of up to 14 days of screening and washout of prohibited medications followed by 6 weeks of double blind treatment followed by a 4-week safety follow-up. The maximum time for participating in the study is 12 weeks, but patients may finish their participation earlier than 12 weeks depending on how they progress in the study. After completing or leaving the study early, patients will no longer have access to the study drug and should discuss other available therapies with the study doctor.
  The study will be conducted at both primary and secondary care Sites within the NHS in the UK.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  19/LO/1553

• Date of REC Opinion

  17 Oct 2019

• REC opinion

  Favourable Opinion