Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

A 4-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety and Efficacy of EVT 101 as Monotherapy in Patients With Treatment-Resistant Major Depression

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01128452

Enrollment

Registered

2010-05-21

Start date

2010-06-30

Completion date

2011-03-31

Last updated

2016-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Treatment-Resistant Depression

Brief summary

This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.

Interventions

DRUGEVT 101

HPMC Capsule, 15 mg, once daily for 28 days

DRUGPlacebo

HPMC Placebo capsules, once daily for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Major Depressive Disorder * Current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens * Has as score of \>/= 18 on the Ham-D-17

Exclusion criteria

* Pregnant or breast-feeding women * Evidence of age-related cognitive decline or mild dementia * At imminent risk of committing suicide * Has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or Parkinson disease * Has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia * Has had a substance or alcohol abuse or dependence disorder (except nicotine and caffeine) in the 1 year before screening

Design outcomes

Primary

Measure	Time frame	Description
Safety and Tolerability Profile of EVT 101	28 days of EVT 101-Treatment	AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires

Secondary

Measure	Time frame	Description
Efficacy of EVT 101 in depression measured using the MADRS score	28 days	Efficacy of EVT 101 in depression measured using the MADRS score and comparing those scores at the end of treatment with scores at baseline
Percentage of patients who respond to treatment with study drug	4 weeks	—
Percentage of patients who experience remission	4 weeks	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026