A Study of Nopan Treatment of Acute Suicidality

Prof. Yoram Yovell

Status and phase: Unknown; Phase 3

Conditions: Suicidality

Treatments: Drug: Placebo; Drug: Nopan

Study type: Interventional

Funder types: Other

Identifiers

NCT01046851

ISAN-001-09

Details and patient eligibility

About

Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist Nopan to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that Nopan may be a novel and quick-acting treatment for acute suicidality. Depression, suicidality, and overall functioning will be assessed before, during and after a four-week Nopan/placebo trial. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of these variables.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• suicidal behavior or ideation (BSI>6)

Exclusion criteria

• ECT history within the last month
• psychotic features within the last 3 months
• history of schizophrenia, substance or alcohol abuse within the last two years
• benzodiazepine dependence within the last two years
• any significant systemic illness or unstable medical condition which does not permit inclusion, according to the research physician
• pregnant women
• patients who currently suffer from severe impairment or severe dysfunction of liver, kidney, adrenal, gall, closed brain injury, urinary retention or respiratory system.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Nopan

Active Comparator group

Treatment:

Drug: Nopan

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo