Effect of Intranasal Insulin on Depressive Symptoms in Major Depressive Disorder

NCT00570050 | Completed Phase 3

• 1 other identifier: Insulin-MDD
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to determine whether adjunctive intranasal insulin will exert an antidepressant effect when compared to placebo in adults with major depressive disorder (MDD), insufficiently responsive conventional antidepressants. There are three secondary aims of the study (1) to determine whether adjunctive intranasal insulin will alter emotional processing (i.e., cognitive-affective interface); (2) to determine whether early changes in emotional processing (i.e., after a single dose at 40IU intranasal insulin) predicts symptomatic improvement at study endpoint; and (3) to determine the effect of intranasal insulin on neurocognitive performance (e.g., learning and memory). This initiative represents a proof-of-concept study that insulin is important to depressive symptoms, neurocognitive functioning, and emotional processing deficits in MDD, representing a novel and safe therapeutic avenue.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder, Memory, Executive function

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  Score form baseline to end of each treatment phase.

  9 weeks

Secondary Outcomes (1)

• Affective Go/No-Go and Emotional Recognition Tasks; CGI Severity of Illness, Improvements in subjective mood (PANAS) and quality of life (Q-LES-Q)

  9 weeks

Study Arms (2)

Intranasal Insulin nasal spray

EXPERIMENTAL

Drug: Diluent / Insulin; Drug: Insulin / Diluent

Placebo nasal spray (i.e., no active treatment)

EXPERIMENTAL

Drug: Diluent / Insulin; Drug: Insulin / Diluent

Interventions

Diluent / Insulin DRUG

Diluent (4 Weeks ) / Intranasal insulin (4 weeks)

Intranasal Insulin nasal spray; Placebo nasal spray (i.e., no active treatment)

Insulin / Diluent DRUG

Intranasal Insulin (4 Weeks ) / Diluent (4 Weeks)

Intranasal Insulin nasal spray; Placebo nasal spray (i.e., no active treatment)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Major Depressive Disorder - current depression

You may not qualify if:

• Unstable medical conditions

Sponsors & Collaborators

• University Health Network, Toronto: lead
• McMaster University: collaborator

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Insulin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Roger S McIntyre

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 10, 2007
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

CA (1)