Effect of erythropoietin (EPO) on memory and concentration difficulties and brain activity in people with previous (hypo)mania and/or depressio

Phase 1

• Conditions: Bipolar disorder and unipolar depression; MedDRA version: 21.1Level: PTClassification code 10057667Term: Bipolar disorderSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: LLTClassification code 10045543Term: Unipolar depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2016-004023-24-DK
• Lead Sponsor: Copenhagen Affective Disorder research Center (CADIC), Psychiatric Centre Copenhagen, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-24
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Patients with bipolar disorder or unipolar depression in remission:

• Bipolar disorder or unipolar depression confirmed with Schedules for Clinical Assessment in Neuropsychiatry (SCAN)-interview
• 18-65 years of age
• Score <=14 on Hamilton Depression Rating Scale 17 items (HDRS-17) and Young Mania Rating Scale (YMRS)
• Cognitive difficulties assessed with the Danish version of the Screen for Cognitive Impairment in Psychiatry (SCIP), defined as a summed score of <=77 or score below cutoff on at least 2/5 subtests (list learning <=21, consonant trigramme task <=18, verbal fluency <=14, delayed list recall <=6, and visuomotor task <=10) on the SCIP-D (Jensen et al., 2015; Purdon, 2005) at the time of inclusion. Cutoff-scores are determined for each subtest in Jensen et al. (2015).

Participants must have adequate levels of Danish language skills to participate in the study.
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 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Previous EPO-treatment
Drug abuse or addiction (including alcohol and benzodiazepines corresponding to >22.5 mg. alopam per day)
Kidney disease
Diabetes
Pregnancy or breast feeding
Women, who use the contraceptive pill or other hormonal contraceptives (not including hormonal coil) and do not want to use hormonal coil, copper coil or double barrier anticontraceptive methods
Sexually active women in the fertile age, who do not or do not want to use hormonal coil, copper coil or double barrier anticontraceptive methods
Previous head trauma
Neurological illness
Smoking
Heart diseases (previously diagnosed or abnormal EKG findings during screening)
Previous or current epilepsy in the participants or his/her first degree family
Previous or current tromboembolic events or tromboses in first degree family occured before the age of 60 (because of increased tromboembolic risk)
Contraindications against profylactic trombosis treatment
Myeloproliferative disorder, polycythemia
Obesity (BMI > 30) or a body weight of <45 kg or >95 kg
Major surgical treatment within 4 weeks before inclusion in the study
Known allergy to or antibodies against EPO
Previous or current cancer disease
Untreated or insufficiently treated hypertension (therapy resistant hypertension defined as a blood pressure over 140/90 mmHg; mean of 3 measures with 2 minute interval morning/midday and evening for three days)
Baseline hematocrit value >50% for men and >48% for women
Thrombocyte numbers over normal (>400 billions/L)
Reticulocyte numbers ERC(B), below 1*10^-3
Reluctance or inability to comply with the protocol requirements, including the presence of any condition (physical, mental or social), which is likely to affect the participant's ability to comply with the protocol
Current somatic disease, which is evaluated as being of importance for patient participation
Electroconvulsive (ECT) treatment within the last 3 months
Dyslexia
Claustrophobia
Pacemaker or metal implantate in the body
Insufficient Danish language skills

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified