Trial record 1 of 1 for:
03739203
The Object of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
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| ClinicalTrials.gov Identifier: NCT03739203 |
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Recruitment Status :
Recruiting
First Posted : November 13, 2018
Last Update Posted : February 12, 2020
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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Brief Summary:
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: Cariprazine Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 750 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | November 10, 2018 |
| Estimated Primary Completion Date : | July 9, 2021 |
| Estimated Study Completion Date : | July 9, 2021 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
MedlinePlus related topics:
Antidepressants
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cariprazine 1.5 mg
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline.)
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Drug: Cariprazine
Cariprazine supplied in capsules |
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Experimental: Cariprazine 3 mg
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2)
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Drug: Cariprazine
Cariprazine supplied in capsules |
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Placebo Comparator: Placebo
During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline.)
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Drug: Placebo
Placebo supplied in capsules |
Primary Outcome Measures :
- Total score change from baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) [ Time Frame: 6 Weeks ]The MADRS is a 10-item, clinician-rated scale that evaluates the patient's depressive symptomatology during the past week. Patients are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent has been obtained
- Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites])
- Patient must be an outpatient at the time of Visit 1 (Screening)
- Patient meets the DSM-5 criteria for MDD based on SCID-5, with a current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
- Diagnosis of MDD confirmed through a formal adjudication process (see Section 6.1)
- Patient demonstrates ability to follow study instructions and likely to complete all required visits
- Patient must have an inadequate response, as measured by the modified ATRQ, to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
- Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
- Male and female patients must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study
- Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2
Exclusion Criteria:
- Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias
- Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739203
Contacts
| Contact: Clinical Trials Registry Team | 877-277-8566 | IR-CTRegistration@allergan.com |
Locations
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Sponsors and Collaborators
Allergan
Additional Information:
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT03739203 |
| Other Study ID Numbers: |
3111-302-001 |
| First Posted: | November 13, 2018 Key Record Dates |
| Last Update Posted: | February 12, 2020 |
| Last Verified: | February 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Allergan:
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MDD |
Additional relevant MeSH terms:
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Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Cariprazine |
Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |