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NMDA Receptor Modulation for the Treatment of Bipolar I Disorder

ConditionBipolar I Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Medical University Hospital

About this trial

At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. NMDA receptor (NMDAR) dysfunction is associated with BD-I, particularly its cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are 18 to 65 years of age;

Satisfy a DSM-5-TR (American Psychiatric Association) diagnosis of BD-I, current episode depressed, after treatment of stable (i.e., at least 4 weeks) and adequate treatment of antipsychotic (quetiapine or lurasidone) and/or mood stabilizer;

Have a 17-item Hamilton Depression Rating Scale (HAMD) score ≥18 and a Young Mania Rating Scale (YMRS) score ≤7 at baseline;

Agree to participate in the study and provide informed consent

Disqualifiers

Current substance abuse or history of substance dependence in the past 6 months

History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study

Schizophrenia or other psychotic disorder

Moderate-severe suicidal risks

Trial design

Design model

Parallel

Treatments tested in this trial

  • NMDAE

    Drug

    Use of an NMDA enhancer for the treatment of bipolar depression

  • Placebo Cap

    Drug

    Use of placebo as a comparator.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: NMDAEExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Visual Continuous Performance Test

Assessment of sustained attention

Time frame
week 0, 8
2

Change in Wisconsin Card Sorting Test

Assessment of abstract and shift set

Time frame
week 0, 8
3

Change in Logical Memory Test of the Wechsler Memory Scale

Assessment of episodic memory

Time frame
week 0, 8
4

Digit Span

Assessment of verbal working memory

Time frame
week 0, 8

Secondary outcomes

1

Change in Quality of life (SF-36)

Time frame
week 0, 8
2

Change in Global Assessmeint of Functioning

Assessment of global improvement. Minimum value: 1, maximum value:100, the higher scores mean a better outcome.

Time frame
Week 0, 2, 4, 6, 8
3

Change in Hamilton Rating Scale for Depression

Assessment of depressive symptoms. Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.

Time frame
Week 0, 2, 4, 6, 8
4

Change in Montgomery-Åsberg Depression Rating Scale

Assessment of depressive symptoms. Minimum value: 0, maximum value:60, the higher scores mean a worse outcome.

Time frame
Week 0, 2, 4, 6, 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University Hospital

Lead sponsor

National Science and Technology Council

Collaborator

Source ClinicalTrials.gov
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