Hippocampal volume in young adults with moderate to severe depression before and after combined antidepressant therapy - C.O.A.T.S

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002788-25-DE

Enrollment

160

Registered

2006-06-02

Start date

2005-08-18

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

moderate to severe depression (episodes and recurrent diseases)

Interventions

Product Name: Trevilor retard Product Code: VENLA Pharmaceutical Form: Capsule, hard INN or Proposed INN: Venlafaxine Current Sponsor code: VENLA Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men and women aging 18-65 years moderate to severe depressive illness (according to ICD10 criteria) and 18 or more points in the Montgomery-Asberg-depression rating scale (MADR-S) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: bipolar affective disorder psychiatric or neurologic comorbidity psychotic depression pregnancy, lactation significant cardiovascular or gastrointestinal disease severe disorder of liver or kidney function

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate, whether the combination of Remergil with another antidepressant (Trevilor ret.) is more effective in reducing depressive symptomatology than is Remergil alone.;Secondary Objective: To evaluate, whether the antidepressant effect starts earlier in combination vs. monotherapy. to evaluate, if side effects occur more or less often during combination vs. monotherapy.;Primary end point(s): Categorical response to treatment. Categorical response is defined on the CGI scale and 50% reduction in the MADR-S sum score.	—

Measure

Time frame

Main Objective: To evaluate, whether the combination of Remergil with another antidepressant (Trevilor ret.) is more effective in reducing depressive symptomatology than is Remergil alone.;Secondary Objective: To evaluate, whether the antidepressant effect starts earlier in combination vs. monotherapy. to evaluate, if side effects occur more or less often during combination vs. monotherapy.;Primary end point(s): Categorical response to treatment. Categorical response is defined on the CGI scale and 50% reduction in the MADR-S sum score.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026