STILDEP: Zolpidem in Depressive and Dysthimic Patients

Sanofi

Status and phase: Completed; Phase 4

Conditions: Sleep Initiation and Maintenance Disorders; Depression

Treatments: Drug: Zolpidem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00292734

L_9259

EudraCT # : 2004-001967-24

Details and patient eligibility

About

Primary objective: To show that the combination of Zolpidem + antidepressant therapy is more effective in the treatment of the secondary insomnia of depressive and dysthimic patients than antidepressant therapy alone in the acute phase of the disease.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Depressive and dysthimic patients in acute phase of mild to moderate severity
• Depressive and dysthimic patients suffering from secondary insomnia (DSM IV) recent antidepressant therapy (less than 1 week)

Exclusion criteria

• Regularly use of sleeping pills in the last 2-3 month
• Use of any sleeping pils in the last week
• Insufficient hepatic
• Myasthenia gravis
• Proven hypersensivity to Zolpidem
• Evidence of clinically relevant nervous system disorders (other neurologic/psychiatric diseases associated with depression)
• History of evidence of alcohol or drug abuse
• Evidence of clinically relevant cardiovascular, haematologic, hepatic, gastrointestinal, renal, pulmonary or endocrinologic diseases
• Abnormal snore
• Work an alternating shift
• Suffering from periodic leg movement disorder and sleep apnea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)