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Cariprazine 3 mg/Day + ADT for Depression

Phase 3

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 6

Awards & highlights

Pivotal Trial

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.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale)

Secondary study objectives

Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score

Side effects data

From 2011 Phase 3 trial • 497 Patients • NCT01058668

17%

Akathisia

11%

Headache

10%

Nausea

10%

Extrapyramidal disorder

10%

Insomnia

Vomiting

Restlessness

Constipation

Dizziness

Dyspepsia

Mania

Diarrhoea

Tremor

Aggression

Hospitalisation

Bipolar disorder

Endometrial cancer

Pulmonary embolism

Bipolar I disorder

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Cariprazine (3-6 mg/Day)

Cariprazine (6-12 mg/Day)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Cariprazine 3 mg/Day + ADTExperimental Treatment1 Intervention

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).

Group II: Cariprazine 1.5 mg/Day + ADTExperimental Treatment1 Intervention

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).

Group III: Placebo + ADTPlacebo Group1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cariprazine

2010

Completed Phase 3

~11050

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