Sequence Towards Remission in Depression (STRIDE)

Jesper Ekelund

Status and phase: Unknown; Phase 4

Conditions: Depression

Treatments: Drug: Placebo; Drug: escitalopram 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01628783

2012-002476-14

Details and patient eligibility

About

In this study the investigators use clinical, biological and imaging markers to develop predictive markers for remission from depression. The investigators compare individuals who have received placebo to individuals who have received 10 mg of escitalopram for one week. In this double-blind, randomized study the investigators a) compare the groups to observe the short-term effects of escitalopram and b) study the predictive value of these observations with respect to remission. Measures include, but are not restricted to, limbic emotional reactivity as assessed by fMRI, emotional processing, emotional memory, autobiographical memory.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major depressive disorder with current major depressive episode according to a SCID-I/P interview
• Montgomery-Åsberg depression rating score 15-30
• Age 18-60

Exclusion criteria

• Borderline, schizoid or schizotypal personality, bipolar or any psychotic disorder
• Primary diagnosis is anxiety disorder: 300.00, .01, .02, .21, .22, .29, .23, .3, 309.81, 308.3, 293.89
• Significant current suicidal ideation, or history of a suicide attempt
• Lifetime substance dependence; Last-year substance abuse; Last month over 24/16 standard doses of alcohol/week; Lifetime use of illicit substances > x5; Any illicit substance use in last month
• Depressive disorder due to medical condition or chemical substance
• Antidepressant medication use in last 4 months
• Severe, unstable somatic illness
• Use of antipsychotics, mood stabilizers, systemic corticosteroids, β-blockers or daytime benzodiazepines (a small dose of ≤10mg zolpidem once daily is permissible)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Microgranular cellulose in gelatine capsules.

Treatment:

Drug: Placebo

Escitalopram 10 mg

Experimental group

Description:

Escitalopram in gelatine capsule

Treatment:

Drug: escitalopram 10 mg