Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Tolerability Of Indiplon Therapy Initiated With Sertraline Versus Sertraline Monotherapy In Subjects With Insomnia And Co-Existing Major Depressive Disorder

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00232167

Enrollment

380

Registered

2005-10-04

Start date

2005-11-30

Completion date

2006-04-30

Last updated

2007-10-02

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

Conditions

Depression, Insomnia

Brief summary

The goal of this study is to determine whether indiplon, when administered with sertraline, improves insomnia symptoms and depressive symptoms in subjects with both insomnia and depression.

Detailed description

This Pfizer run study stopped due to the co-development program for indiplon being terminated between Pfizer and Neurocrine. The study was terminated on 16 November 2006. There were no safety issues leading to the decision to terminate this study.

Interventions

DRUGIndiplon

DRUGSertraline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* DSM-IV defined insomnia * DSM-IV defined Major Depression

Exclusion criteria

* Current suicidal ideation or behavior * Primary sleep disorder other than insomnia

Design outcomes

Primary

Measure	Time frame
Change from baseline to week 1 in subjective total sleep time (sTST); (average of the week one data)	—

Secondary

Measure	Time frame
Change from baseline in subjective total sleep time (sTST). Change from baseline in subjective parameters: LSO, sWASO, sNAASO, Sleep Quality (IVR). Change from baseline in the 3-item HAM-D insomnia factor (items #4-6).	—

Outcome results

None listed

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