A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01655680
• Collaborator: (none)
• Enrollment: 432
• Locations: 61
• Arms: 4
• Duration (Months): 26
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a safety and efficacy study evaluating a experimental treatment for cognitive deficits in adults with schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: ABT-126; Drug: ABT-126; Drug: ABT-126; Drug: Placebo	Phase 2

Detailed Description

This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-126 in treating cognitive deficits in subjects with a diagnosis of schizophrenia. Eligible subjects will take study drug as an add-on treatment to their ongoing antipsychotic treatment regimen.

Study Design

• Study Type: Interventional
• Actual Enrollment: 432 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Nonsmokers
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-126 Low Dose ABT-126 Low Dose	Drug: ABT-126; ABT-126 Low Dose
Experimental: ABT-126 Middle Dose ABT-126 Middle Dose	Drug: ABT-126; ABT-126 Middle Dose
Experimental: ABT-126 High Dose ABT-126 High Dose	Drug: ABT-126; ABT-126 High Dose
Placebo Comparator: Placebo Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Cognition: MCCB (MATRICS Consensus Cognitive Battery) [Change from baseline to week 24]

   Rater based interview

Secondary Outcome Measures

1. Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2) [Measurements from screening period up through week 24]

   Rater based interview

2. Symptom Severity: PANSS (Positive and Negative Symptom Scale) [Measurements from screening period up through week 24]

   Rater based interview

3. Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale) [Measurements from screening period up through week 24]

   Rater based interview

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.).

• Is clinically stable while receiving a regimen of one or two allowable antipsychotic medications: lack of hospitalizations in 4 months prior to initial screening visit; taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline visit; core positive symptoms of Positive and Negative Syndrome Scale (PANSS) no worse than moderate in severity throughout screening period of at least 4 weeks.

• Has been diagnosed with or treated for schizophrenia for at least 2 years prior to initial screening visit.

• Has had continuity in psychiatric care (e.g., mental health system, clinic or physician) for at least 6 months prior to initial screening visit.

• Has an identified contact person (e.g., family member, social worker, case worker, or nurse) that can provide support to the subject to ensure compliance with protocol requirements.

Exclusion Criteria:

• In the Investigator's judgment, has a current or past diagnosis of schizoaffective disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder, or obsessive-compulsive disorder, or the subject has a current major depressive episode.

• Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines during the Screening Period.

• Has a current or past history of seizures, with the exception of a single febrile seizure occurring prior to 6 years of age.

• Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.

• Has any risk factors for Torsades de Pointes (TdP)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 75139	Anaheim	California	United States	92804
2	Site Reference ID/Investigator# 74894	Bellflower	California	United States	90706
3	Site Reference ID/Investigator# 74434	Chino	California	United States	91710
4	Site Reference ID/Investigator# 76593	Costa Mesa	California	United States	92626
5	Site Reference ID/Investigator# 73213	Escondido	California	United States	92025
6	Site Reference ID/Investigator# 72698	Garden Grove	California	United States	92845
7	Site Reference ID/Investigator# 75057	La Habra	California	United States	90631
8	Site Reference ID/Investigator# 72693	National City	California	United States	91950
9	Site Reference ID/Investigator# 77655	Norwalk	California	United States	90650
10	Site Reference ID/Investigator# 74895	Oakland	California	United States	94612
11	Site Reference ID/Investigator# 73977	Oceanside	California	United States	92056
12	Site Reference ID/Investigator# 73214	Orange	California	United States	92868
13	Site Reference ID/Investigator# 74453	Pico Rivera	California	United States	90660
14	Site Reference ID/Investigator# 74898	Riverside	California	United States	92506
15	Site Reference ID/Investigator# 98016	San Bernardino	California	United States	92408
16	Site Reference ID/Investigator# 86973	San Diego	California	United States	92102
17	Site Reference ID/Investigator# 75140	San Diego	California	United States	92103
18	Site Reference ID/Investigator# 73974	San Gabriel	California	United States	91776
19	Site Reference ID/Investigator# 74433	Santa Ana	California	United States	92705
20	Site Reference ID/Investigator# 72695	Torrance	California	United States	90502
21	Site Reference ID/Investigator# 75136	New Haven	Connecticut	United States	06519
22	Site Reference ID/Investigator# 75653	Atlanta	Georgia	United States	30308
23	Site Reference ID/Investigator# 74893	Marietta	Georgia	United States	30060
24	Site Reference ID/Investigator# 72697	Chicago	Illinois	United States	60640
25	Site Reference ID/Investigator# 76533	Hoffman Estates	Illinois	United States	60169
26	Site Reference ID/Investigator# 75056	Wichita	Kansas	United States	67214
27	Site Reference ID/Investigator# 72694	Cedarhurst	New York	United States	11516
28	Site Reference ID/Investigator# 75137	Rochester	New York	United States	14623
29	Site Reference ID/Investigator# 75053	Staten Island	New York	United States	10312
30	Site Reference ID/Investigator# 75413	Philadelphia	Pennsylvania	United States	19139
31	Site Reference ID/Investigator# 74553	Dallas	Texas	United States	75231
32	Site Reference ID/Investigator# 72696	DeSoto	Texas	United States	75115
33	Site Reference ID/Investigator# 75055	Houston	Texas	United States	77008
34	Site Reference ID/Investigator# 74896	Houston	Texas	United States	77098
35	Site Reference ID/Investigator# 94476	Chita		Russian Federation	672090
36	Site Reference ID/Investigator# 79515	Ekaterinburg		Russian Federation	620030
37	Site Reference ID/Investigator# 94528	Kazan		Russian Federation	420061
38	Site Reference ID/Investigator# 79517	Lipetsk		Russian Federation	399083
39	Site Reference ID/Investigator# 81934	Moscow		Russian Federation	107076
40	Site Reference ID/Investigator# 81935	Moscow		Russian Federation	109559
41	Site Reference ID/Investigator# 79516	Moscow		Russian Federation	115419
42	Site Reference ID/Investigator# 83116	Novosibirsk		Russian Federation	630064
43	Site Reference ID/Investigator# 97136	Saint-Petersburg		Russian Federation	195176
44	Site Reference ID/Investigator# 81933	Saratov		Russian Federation	410028
45	Site Reference ID/Investigator# 79514	Saratov		Russian Federation	410060
46	Site Reference ID/Investigator# 80673	St. Petersburg		Russian Federation	190020
47	Site Reference ID/Investigator# 85093	St. Petersburg		Russian Federation	190121
48	Site Reference ID/Investigator# 97135	St. Petersburg		Russian Federation	191119
49	Site Reference ID/Investigator# 97137	St. Petersburg		Russian Federation	191119
50	Site Reference ID/Investigator# 83115	St. Petersburg		Russian Federation	192019
51	Site Reference ID/Investigator# 84733	St. Petersburg		Russian Federation	197341
52	Site Reference ID/Investigator# 79520	Stavropol		Russian Federation	357034
53	Site Reference ID/Investigator# 83117	Yaroslavl		Russian Federation	150003
54	Site Reference ID/Investigator# 97138	Yekaterinburg		Russian Federation	620028
55	Site Reference ID/Investigator# 81938	Brentford		United Kingdom	TW8 8DS
56	Site Reference ID/Investigator# 81940	Edinburgh		United Kingdom	EH10 5HF
57	Site Reference ID/Investigator# 81939	London		United Kingdom	SE5 8AF
58	Site Reference ID/Investigator# 92813	London		United Kingdom	W6 8RP
59	Site Reference ID/Investigator# 81937	Newcastle upon Tyne		United Kingdom	NE4 5PL
60	Site Reference ID/Investigator# 81943	Oxford		United Kingdom	OX3 7JX
61	Site Reference ID/Investigator# 82238	Preston		United Kingdom	PR5 6YA

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: George Haig, PharmD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01655680
• Other Study ID Numbers: M10-855; 2012-000418-13
• First Posted: Aug 2, 2012
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by AbbVie (prior sponsor, Abbott): Schizophrenia
• Additional relevant MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction

Study Results

No Results Posted as of Jul 7, 2021