Bipolar disorder and unipolar depression MedDRA version: 21.1 Level: PT Classification code 10057667 Term: Bipolar disorder System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: LLT Classification code 10045543 Term: Unipolar depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Eprex
Product Name: Eprex
Pharmaceutical Form: Injection
INN or Proposed INN: Erythropoietin (EPO)
CAS Number: 11096-26-7
Other descriptive name: ERYTHROPOIETIN
Concentration unit: IU inte
Sponsors
Copenhagen Affective Disorder research Center (CADIC), Psychiatric Centre Copenhagen, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate the effect of 12 weeks of erythropoietin (EPO) treatment on cognitive impairments in patients with bipolar disorder or depression in remission with cognitive difficulties;Secondary Objective: The secondary objective is to investigate whether an early change in neural activity in prefrontal cortex correlates with and predicts improvements of cognitive functions in patients with bipolar disorder or depression in remission with cognitive difficulties;Primary end point(s): Difference in the change of: (i) A collected measure of cognition (a composite score) encompassing the following measures: Rey Auditory Verbal Learning Test – Total Recall (RAVLT; Schmidt, 2004), the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding (Randolph, 1998), verbal fluency (with letter "D"; Borkowski, Benton, & Spreen, 1967), WAIS-III Letter-Number Sequencing (Wechsler, 1997), Trail Making Test Part B (TMT-B; Army Individual Test Battery, 1944), and Rapid Visual Processing (RVP) from Cambridge Neuropsychological Test Automated Battery (CANTAB), which cover attention, verbal learning and memory, and executive functions.;Timepoint(s) of evaluation of this end point: Primary end points will be evaluated at baseline (week 1), week 3 (2 weeks after treatment initiation), week 13 (1 week after treatment ending), and at 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in the change of: (i) Cognition (attention and processing speed) measured with Rapid Visual Processing (RVP; CANTAB) (ii) Function and quality of life measured with: the Functional Assessment Short Test (FAST; Rosa et al 2007);Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated at baseline (week 1), week 3 (2 weeks after treatment initiation), week 13 (1 week after treatment ending), and at 6 months follow-up | — |
Countries
Denmark
Contacts
Public ContactLars Vedel Kessing
Copenhagen Affective Disorder research Center (CADIC), Psychiatric Centre Copenhagen, Rigshospitalet
Outcome results
None listed