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An investigation of the clinical efficacy of amantadine on depressive syptoms and cognitive deficits in Borna Disease Virus (BDV) infected patients with an affective psychosis; a prospective, randomized, double-blind, placebo controlled, monocentric study.

An investigation of the clinical efficacy of amantadine on depressive syptoms and cognitive deficits in Borna Disease Virus (BDV) infected patients with an affective psychosis; a prospective, randomized, double-blind, placebo controlled, monocentric study.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00007649
Enrollment
40
Registered
2015-03-04
Start date
1997-04-28
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

F31.3 F31.4 F32.1 F33.1 F33.2

Interventions

Group 1: 200 mg of amantadine or placebo as add-on treatment. Cross-over after six weeks. Group 2: 200 mg of amantadine or placebo as add-on treatment. Cross-over after six weeks.

Sponsors

Medizinische Hochschule Hannover
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Acutely depressed patients requiring treatment, according to the ICD-10 classification: F31.3, 31.4, 31.5 as well as F33.0, F33.1, F33.2, F33.3 and the respective DSM-IV criteria Men and women between 30 and 70 years of age Informed consent of the patient

Exclusion criteria

Exclusion criteria: Suspected exogenous depression Hypersensitivity against ingredients of amantadine or the placebo Conditions in which the use of amantadine is contraindicated (e.g. clinically relevant renal insufficiency) Other severe systemic conditions (e.g. cardiovascular conditions, blood coagulation disorders, malignancies requiring palliative care, collagenoses or florid infections) Current pregnancy or breastfeeding Compulsory in-patient treatment Unability to give informed consent

Design outcomes

Primary

MeasureTime frame
Change of HAMD rating results after 6 weeks of treatment and BDV activity comparing amantadin and placebo group

Secondary

MeasureTime frame
Beck Depression Inventory (BDI) von Zerssen's Mental State Scale (Bf-S) Symptom Checklist (SCL) Global Assessment Scale (GAS) Cognitive Functions

Countries

Germany

Contacts

Public ContactDetlef Dietrich

Medizinische Hochschule Hannover

dietrich.detlef@mh-hannover.de+49 511 532 6571

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 28, 2026