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Neuroendocrinological effects of lithium and citalopram on the cortisol regulation of patients with major depression

Neuroendocrinological effects of lithium and citalopram on the cortisol regulation of patients with major depression - LiCo study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003185
Enrollment
60
Registered
2011-07-06
Start date
2003-03-13
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

F32 F33

Interventions

Group 1: Lithium monotherapy. Initial dosage: 2x12,2 mmol/d p.o. Individual adaption to achieve serum levels between 0.6 and 0.8 mmol/L. Lithium serum level will be determined at days 3, 7, 14, 21 an

Sponsors

Klinik für Pschiatrie und Psychotherapie Universitätsklinikums Carl Gustav Carus an der Technischen Universität Dresden
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: diagnosis of a major depression according to DSM-IV, SCID I confirmed; at least 15 points on the Hamilton Rating Scale for Depression (21 item version); indication for a antidepressive pharmacotherapy independently of the study; oral and written informed consent; ability to give informed consent

Exclusion criteria

Exclusion criteria: manic or hypomanic episode in history (bipolar disorder); psychotropic medication within one wek prior to enrollment (one week wash out if neccessary); 20 mg/d diazepam or an equivalent dosage of another bezodiazepine are allowed prior and during the study; severe medical condition; conditions that contraindications to SSRIs or lithium or to the Dex/CRH test (e.g. severe renal dysfunction, severe cardial dysfunction, dysfunction of glucocorticoid or mineralocorticoid regulation); pregnancy; breast feeding; unsecure contraception; other axis I diagnoses beside the affective disorder; substance dependency

Design outcomes

Primary

MeasureTime frame
area under the curve (AUC) for cortisol and for ACTH comparing AUCs before treatement with AUCs after four weeks of pharmacotherapy

Secondary

MeasureTime frame
clinical efficacy as assessed by weekly ratings with the psychometric scales HAMD, BDI and CGI

Countries

Germany

Contacts

Public ContactTom Bschor

Klinik für Pschiatrie und Psychotherapie des Universitätsklinikums Carl Gustav Carus an der Technischen Universität Dresden

bschor@mailbox.tu-dresden.de+49-351-458-2797

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 27, 2026