Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Acadia Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Adjunctive Treatment of Major Depressive Disorder

Treatments: Drug: Pimavanserin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03968159

2018-003251-37 (EudraCT Number)

ACP-103-054/059

Details and patient eligibility

About

To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy

Full description

Two separate studies, idential in design, were planned and initiated under 2 protocol IDs and NCTs, i.e. study ACP-103-54 (NCT03999918) and ACP-103-059 (NCT03968159). In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled.

This entry now includes the combined data of studies ACP-103-054 and ACP-103-059.

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients, aged 18 years and above

2. A clinical diagnosis of major depressive disorder (MDD)

3. Is being treated with one of the following SSRI or SNRI antidepressants:

   1. Citalopram
   2. Escitalopram
   3. Paroxetine
   4. Fluoxetine
   5. Sertraline
   6. Duloxetine
   7. Venlafaxine
   8. Desvenlafaxine
   9. Venlafaxine XR

4. Inadequate response to SSRI/SNRI antidepressant treatment is confirmed

5. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception

Exclusion criteria

1. Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
2. Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
3. Has a known history or symptoms of long QT syndrome
4. Is determined to be inappropriate for the study for any reason

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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298 participants in 2 patient groups, including a placebo group

Drug - pimavanserin

Experimental group

Description:

Pimavanserin 34 mg tablets

Treatment:

Drug: Pimavanserin

Placebo

Placebo Comparator group

Description:

Placebo tablets

Treatment:

Drug: Placebo